Świat Przemysłu Farmaceutycznego 3/2010 EN

NR 03/2010 (13) 10 zł (w tym 0% VAT)

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contents 15

20

38

8

Adamed introduces INSIDE

10

Klopidogrel

12

A few words about securities

15

Class action in Poland since 19 July 2010

18

Change Management: Innovation in e-Regulatory Processes

20

How to extend patent protection for a medicinal product?

24

Nycomed worldwide

27

Polski Holding Farmaceutyczny is selling Polfa Tarchomin

28

Sanfarm Sp. z o.o. – the youngest pharmaceutical industry plant in Podkarpacie Region

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12

31

2 Congress World of the Pharmaceutical Industry

34

Imaging diagnostics market in Poland

36

Production outsourcing scope

38

The role of statistics in risk analysis in the pharmaceutical industry

42

Blazing a future-proof process path

44

Methods of granulation

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36

54

34

59

47

50

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Innovation instruments and techniques in pharmaceutical industry

High sophisticated coating equipment for manufacturing of high sophisticated pharmaceuticals

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54

On time delivering medicines

56

Pharmaceutical logistics and its requirements

59

Electronic commerce for the sake of pharmacy – Part II - Conditions of using barcodes

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coming soon...

I am pleased to present you with another bilingual edition of the “World of the Pharmaceutical Industry” quarterly, describing this year’s numerous industry events taking place in Poland and abroad.

The Farmacom publishing house and the editors of the “Świat Przemysłu Kosmetycznego” / World of the Cosmetic Industry / quarterly together with the Honorary Host - Laboratorium Kosmetyczne Dr Irena Eris S.A. are pleased to invite you to attend our Congress of World of the Cosmetic Industry, which will take place on 13–14 October 2010 at the Centrum Konferencyjno - Szkoleniowe „BOSS” in Warsaw.

For this specialist industry meeting, devoted to the latest trends, technologies, machinery and equipment used in cosmetic manufacture, we invite: technology and automation specialists, heads of production, control and quality assurance, heads of logistics and procurement and heads of product development at cosmetic companies and representatives of firms dealing with and supplying the cosmetic sector.

The thematic scope of the Congress will include all of the main stages of cosmetic production, from ingredient procurement up to the warehousing and forwarding of finished products.

You are warmly invited to attend!

Editor-in-chief „Świat Przemysłu Farmaceutycznego”

Programme Board Grzegorz Cessak – President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Andrzej Szarmański – President of ISPE Poland, Quality Director at Polpharma SA Pharmaceuticals

Irena Rej – President of the Polish Pharmaceuticals Chamber of Commerce

prof. dr hab. Zbigniew E. Fijałek

Daniel Gralak

– director of the National Medicines Institute

– Director of GMP Inspection Department in Main Pharmaceutical Inspectorate

Marcin Kołakowski – Vice President for Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Marek Gnyś – chief technologist Polfa Warszawa

dr Jarosław Jan Hołyński – Polish Pharmaceutical Association

dr n. farm. Leszek Borkowski – EU expert of the matters of medicines, former President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

List of advertisers: Awbud Sp. z o.o.

Quarterly, published by FARMACOM Wodzisław Śląski 44-300 ul. 26 Marca 31/11 farmacom@farmacom.com.pl www.farmacom.com.pl Editor-in-chief Robert Miller tel./fax +48 32 455 31 61 tel. kom. +48 502 084 101 robert.miller@farmacom.com.pl Subscription and distribution FARMACOM Wodzisław Śląski 44-300 ul. 26 Marca 31/11 tel./fax +48 32 455 31 61 prenumerata@farmacom.com.pl Issue price „ŚPF” – 10 zł Annual subscription price – 35 zł

Payments may be made to the account: ING Bank Śląski O/Wodzisław Śląski 56 1050 1403 1000 0023 2091 8119

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Bio-Chic Sp. z o. o.

DAMCO Poland Sp. z o.o.

Editors

ECOLAB Sp. z o.o.

Maria Kubsz, Tomasz Butyński, Teresa Kubsz-Miller, tel./fax +48 32 456 60 79 redakcja@farmacom.com.pl

EDELMANN Poland

DTP : Wiktor Adamiec wiktor.adamiec@farmacom.com.pl

Irtech

Printing: Drukarnia BIMART

Kujawskie Zaklady Poligraficzne DRUK-PAK S.A.

Number of copies printed: 2 500

Lorien Engineering Solutions Limited Sp. z o.o.

Partner:

OFTIM S.C.

ERWEKA Poland Sp. z o.o.

GALBEX PRO Sp. z o.o.

I.E.S. International Polska Sp. z o.o.

KOMENDER TECHNOLOGIES

PHZ i ITH INTREX PP GAL RADWAG www.ispe.org.pl

The magazine is addressed to process and production engineers, automatic systems specialists, heads of production, control and quality assurance divisions, heads of logistics and procurement divisions and product development divisions at pharmaceutical companies. The magazine is also purchased by organizers of trade fairs, conferences and industry training courses, government offices, ministries, institutes, higher educational institutions offering pharmaceuticalsrelated courses, and design firms. The editors reserve the right to shorten and edit material.

The editors are not responsible for the content of advertisements. The use of materials and publication of advertisements produced by the publisher is permitted only with the editors’ consent.

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BART S.J.

Sartorius Mechatronics Poland Sp. z o.o.

Sartorius Stedim Poland Sp. z o.o.

TESSA S.J. TRADE&CONSULT Sp. z o.o. Sp. k.

Zakład Usług Komputerowych i Biurowych PROBIT Zakład Poligraficzny „Wiking Graf” S.J. ZMR S.J.

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8 | Polish industry

Adamed introduces INSIDE Robert Miller

Adamed – a leading Polish pharmaceutical manufacturer, as part of its new Adamed Consumer Healthcare, has introduced its own innovative INSIDE line of dermocosmetics on to the market.

Warsaw, 10th June2010 – Adamed Consumer Heathcare, on the basis of its experience–has developed and decided to promote its innovative INSIDE dermocosmetics. The brand currently consists of three lines of preparations. Prebiotine are dermocosmetics aimed at acne skin.

The Synactive 30+ and Synactive 40+ lines have been created with an eye to modern skin care for the over-30s and 40s. The company is planning to develop further lines for other age groups and dermatological problems. INSIDE dermocosmetics are now available from chemists.

Women expect visible and permanent effects from dermocosmetics. The INSIDE brand is an innovative answer to the needs of modern, demanding Polish women. The preparations we offer are created using not only high pharmaceutical standards, but also patented formulae which represent the latest solutions in medicine and cosmetology. We believe that rich experience in the field of medicine is the key to achieving success on the dermocosmetics There is more information on INSIDE dermocosmetics available on: www.inside-derm.pl

market,” says Małgorzata Adamkiewicz, Vice chairwoman and Managing Director of Adamed.

Adamed Leader on the Polish market of new generation medicines for many therapeutic groups, including cardiology, psychiatry, pulmonology, gynaecology and treatment of urinary infections.

Adamed is involved in research into innovative treatments for lifestyle diseases. The company is currently working on three research programmes. It is seeking innovative therapies with applications in treating type 2 diabetes, and drugs which will be the Polish answer to diseases of the central nervous system. Work is also under way to develop an effective anti-cancer therapy acting selectively on cancer tissue. The company’s laboratories have developed over 20 patents for their own medical formulae. Another 3 patent applications concerned innovative molecules.

In 2010, Adamed made two acquisitions – it purchased Polfa Pabianice and Agropharm. The company, with 100% Polish capital was formed in 1986. The Chairman of its Board of Management is Maciej Adamkiewicz.

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10 | Polish industry

Klopidogrel Robert Miller

Adamed, thanks to its effective management, has shown income of 11.05m pln from the sale of Polish cropidogrel.

In August 2009, Adamed successfully completed registration of

Drugs containing clopidogrel are used in treating acute coronary

a cardiological medicine with cropidogrel as an active substance.

syndrome, strokes and in diseases of the arteries. Clopidogrel signi-

The medicine the pharmaceutical company produces is the first Polish

ficantly reduces mortality from heart attacks. The European Society

medicine to pass the European DCP (Decentralized Procedure) registra-

of Cardiology, in its notes regarding “Prevention in Sufferers of

tion. Sales of Polish clopidogrel on foreign markets between 2009 and

Sclerosis of the Coronary Arteries and Other Arteries” recommends

May 2010 have brought Adamed in a total turnover of over 10m pln.

that every patient takes Clopidogrel after an attack of acute coronary

“Our aim was to introduce Polish clopidogrel on to the markets of Central

syndrome (ACS) or after percutaneous coronary intervention (PCI) with a stent implanted.

and Eastern Europe. Last year we began deliveries of our product to the Czech

Clopidogrel – prescribed for adults for thrombosis prevention

Republic, Estonia, Lithuania, Slovenia,

in symptomatic atherosclerosis:

Latvia, Romania, Slovakia, Bulgaria and

• For heart attack patients (several days to under 35 days), with

Hungary. The registration we received gave us and our partners the opportunity to introduce clopidogrel on to several markets simultaneously. Since sales are

a stroke (for 7 days to under 6 months) and recognised diseases of the circulatory arteries.

• For patients with Acute Coronary Syndrome: ‫ ٶ‬Without raising the ST section (unstable ischaemic heart di-

only now intensifying we are counting on

sease or heart attack without Q-breakage) including patients

income from sales of the drug to increase

who have been implanted with a stent during a percutaneous

in the long run,” said Kamila Dobrowolska,

angioplasty operation in conjunction with acetylsalicylic acid

Director of Adamed’s Foreign Projects Department.

(ASA), ‫ ٶ‬With acute heart failure and raised ST section, in conjunction with ASA, in patients being treated conservatively and

Kamila Dobrowolska

qualifying for thrombolytic treatment.

Director of Adamed’s Foreign Projects Department

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e-w ydanie do pobrania na:

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adverti

100 95 75

25 5 0

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12 | Polish industry

A few words

about securities Tomasz Wojciechowski Kujawskie Zakłady Poligraficzne Druk-Pak S.A.

The analysts of economic markets underline the fact that a pharmaceutical sector is one of the very few industrial sectors which has resisted the impact of the recent global crisis or has been affected by its effects in a minimal degree. Together with a pharmaceutical sector, in the same very comfortable situation, have been the companies operating in related or supporting sectors such as manufacturers of packaging or printers of medical leaflets. This does not mean however, that the companies operating in this field could have afforded to assume a passive or an anticipating attitude to their customers during the economic crisis. Paradoxically, crisis waves in economics are a good opportunity to strengthen one’s competitive advantage while consumers’ expectations are strengthened and tightly binding during such a period.

It has been in the period of the last 2 – 3 years that at the shelves of pharmacy

files. The system, the operation of which is based on a computer station,

shops and other retail points of sale one could see a boost of numerous carton

a scanner and a graphic software application, is characterised by a simple

box packagings for medicines and parapharmaceuticals which have attracted

construction, high accuracy of reading and measurement, as well as the

potential customers with sophisticated forms of surface finish such as stamping

possibility of application of various filters which allow for a selective control

(Manti, Magnefar B6), gold-plating (ex. a last version of Capivit) or film covered

of files. Due to those features Pharma Print Control pre - press tests can be

openings. Also, the expectations regarding the assurance of a product safety

carried at various levels. The system allows for:

already at the stage of packaging design and an appropriate marking of product

• a verification of files (PDF) against print - outs from a current production,

genuity have been raised. This requirement has been strongly underlined both by

• a verification of files (PDF) against print - outs from a former production

manufacturers and distributors of medicines as well as their consumers.

at repetitive orders, • carrying of a comparative analysis against the colour scheme template of

Pre-press Process Safety At present, there are only a few printing houses in Poland that manufacture packagings for pharmaceuticals which, by means of implementation of strict quality standards (such as ISO 15378), assure the safety of a manufacturing process at each stage of its implementation.

an orderer, • an analysis of base colours, • a control of the correctness of text contents in a graphic layout (an elimination of errors, mixed up or omitted letters etc), • a control of correctness of location of Braille texts on a packaging.

First stage of a manufacturing process is a so called pre-press stage which consists in the elaboration of a construction and a graphic design of a

Yet another manner of assuring of a product safety at the pre-press

packaging. At this stage, on the basis of electronic data, the files for a carton

stage, which assures reliability of packaging contents to a final consumer,

packaging manufacturing are being prepared. Hovever, a computer is just a

is the system of test print - outs which are submitted to a customer for

piece of software and harware, which can break down or spontaneously

a final approval. The proofing system as such is not new in the printing

alter elements in files. Therefore, the usage of a highly sophisticated

methodology, yet not all manufacturers are inclined to have it applied. One of

and specialised application software such as Pharma Print Control seems

the leading printing plants in Poland implemented last year a latest version of

to be of an advantage, which, at the stage of the elaboration of files for a

GMG FLEXO PROOF version 05. In this system the data allowing for colour

manufacturing process, allows for the control of conformity of the so called

management are “downloaded” from an offset printing machine and calibra-

reference files (received for an orderer) with the elaborated manufacturing

ted to the parameters of a standard printer which fact eventually allows for

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Polish industry | 13

printing of proofs with the parameters which shall eventually be obtained at

medical products. The acts of purchasing of such products are mosty

a standard printing process. A customer has then a possibility of a personal

carried unintentionally and in good faith. A consumer is not aware that

verification whether the final apprearance of a carton packaging meets his

a purchased product is not original and fake, of hardly any medical

/ her expectations. If a final product does not meet the expectations there is

value and sometimes even detrimental in its effects. In some European

still a possibility of making corrections without a need of printing of dozens

countries the percentage of bought fake products equals as much as

or sometimes even hundreds of test sheets directly on a printing machine.

38% of the total purchase of pharmaceutical products. The above data

The aspect of time and raw material saving is worth underlining here.

indicate the huge extend of the problem. Manufacturers and distributors

Printing plants that have implemented such solutions can assure their

of medical products have been fighting for years with dishonest sellers of

customers that they can have a document recorded certainty regarding the

counterfeited medical products, yet the administrative methods applied

correctness of a pre-press production preparation stage. Moreover, such

seem not to be very effective. Hence an initiative of introducing of a

an arrangement of the process constitutes a subsequent, higher and more

highly specialized marking on packagings has been developed aimed

advanced level in quality and final product safety assurance, which fact is of

at facilitating an easy recognition of original medicines and making

a critical value in a pharmaceutical sector.

launching of fake products much more difficult. This initiative has been becoming more and more important in the packaging sector in recent

Securing of Printed Packaging.

It it hard nowadays not to find a sector in which manufacturers do

times. Presently, printing manufactures have various technology and packaging securing methods at their disposal. One of them, nowadays

not suffer from counterfeiting of their products. Unfortunately, these

becoming already a bit outdated, is placing of holograms on the surface

very punishable acts are also affecting a pharmaceutical sector in a very

of a carton box. Unfortunately, a possibility of their easily counterfeiting

growing manner. Each year the number of new fake medical products

has soon after been developed. Another presently applied method of

launched on the market is increased. According to a research carried

carton box surface securing is, among others, an application of various

by one of renowned pharmaceutical holdings, Europeans spend about

unique types of printing inks such as:

10.5 billion EUR per annum for medicines from unrecognizable sources.

• optically variable inks (OVI), which change colour depending on an angle

According to the World Health Organization the spend for fake medicines in Poland equals 100 million Polish zloty per annum. The research indicates that last year one in five inhabitants in Europe bought fake

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of observation or an angle of incidence of light, • thermochromic inks, which change colour depending on an applied temperature.

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14 | Polish industry The above presented inks can change colour permanently or temporarily, Twin effect

disappear (become invisible in visible light), or being generally invisible, appear temporarily or permanently in the presence of specific external factors.

• photochrome inks, which change colour in the presence of light, • luminescent inks, which are active in UV radiation of various ranges, • reactive inks, which enter into irreversible chemical reactions at the trial of removal of even a part of print ex. a change of texts on the packaging, • magnetic inks – the print made with magnetic inks reacts to strong magnetic impact, • opalescent inks – which contain macroelements, which form a thin leyer which interferes with scattered light and results in a glossy, pearl-like effect which changes colour at the change of an angle of observation or lighting, • transparent inks, which provide a pearl-like gloss at a specific angle of observation, • so called Yet another manner of securing of a packaging surface is the application of an appropriate type of varnish ex. an oil varnish, which, applied in a specific manner provides a so called “twin effect”, which consists in the appearance of graphic elements on a surface of packaging, which are visible exclusively at an appropriate angle of observation.

The above technology has been successfully applied on packaging of medical products for already some time.

A graphic cover itself also offers various opportunities of special marking of a product. Microprint, for instance, has been more and more widely applied nowadays. However, the newest achievement in this field is a so called “latent print”. “Latent print” consists in the placement in a print cover of small graphic elements visible only after a large magnification and which are hard for identification by an unaided eye. “Latent print” is applied with a different technology than microprint and is a trade secret of professionals in this field.

From the above presentation of current possibilities of securing of carton boxes one can see that customers have currently at their disposal quite a wide selection of posssibilities of printing methods and technologies that can be applied to secure products against conterfeiting. It comes without saying that not all printing houses can offer the full range of the above presented printing methods and technologies, as they require the use of appropriate equipment and tools, appropriate pre - print and manufacturing processes and, finally, the application of appriopriate legal arrangements on confidentiality with the suppliers of required components.

Constinuously increasing competition forces suppliers of pharmaceutical packaging to undertake various activities aimed at broadening of their manufacturing competence and skills and their mindful presentation to potential buyers. Also a specific technological know-how and skills are required in order to apply those solutions in practice. Professional combination of those elements in practice is not easy and requires considerable investment not only in the stock of machine tools, but also in the personnel.

On the other hand, one shall count on the social responsibility awareness of medical manufactures that should motivate them to further apply more and more sophisticated security measures on pharmaceutical packaging in order that the principle “Primum Non Nocere” has not been just a void slogan and has had a meaning much wider than at present.

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Polish industry | 15

Class action in Poland since 19 July 2010 – a discussion on the basis of the Act of Law of 17 December 2009 on pursuing claims in collective proceedings Jolanta Budzowska, Joanna Bębenek-Lazer Kancelaria Budzowska Fiutowski i Partnerzy

The experience of other European countries shows that the institution of class action lawsuits is conservatively used, but once the collective action is filed, it makes waves and, on the one hand, it constitutes an effective tool for victims to duly obtain compensation and, on the other hand, it generally has an adverse effect for the company’s goodwill which results in measurable financial losses.

What is understood by the term ‘collective claims’?

It is definitely too early to strictly assess or predict potential advantages that can be triggered off in the Polish legislation due to the

Jolanta Budzowska

issuance of the act on pursuing claims in collective proceedings.

– legal counsellor from BUDZOWSKA FIUTOWSKI AND PARTNERS. LEGAL COUNSELLORS in Kraków; Board Member of PEOPIL organization; her field of specialisation includes civil law, in particular claims for compensation.

A new pattern of pursuing claims will have to be undoubtedly mastered both by potential victims and the companies forced to file a defence against class action. New institutions such as the specific agreement with the counsel, the contract between the representative of the group and a group itself (and the rules of joining the group by its members), the issue of demanding deposit and the question of a defence against a plaintiff’s obligation to make a deposit – they all require blazing trails and creating accurate patterns.

It can be assumed that due to the complicated procedure the new type of proceedings will commence in such cases where the standardized claim is relatively high, because it is only in such situations that the

Joanna Bębenek-Lazer – graduated in law, Business Development Manager from BUDZOWSKA FIUTOWSKI AND PARTNERS. LEGAL COUNSELLORS in Kraków.

potential benefits justify the organizational effort. The latter means trouble for companies, because class action cannot be underestimated,

action is filed, it makes waves and, on the one hand, it constitutes an

even at the very start of this new institution in the Polish legal system.

effective tool for victims to duly obtain compensation and, on the other

This new regulation will be certainly widely applied in actions relating

hand, it generally has an adverse effect for the company’s goodwill which

to liability for unsafe products including actions for compensation due

results in measurable financial losses. We shall then be prepared that

to damage caused by side effect of medication and damage caused as a

class actions will be brought and it is our duty to work out in advance

result of a medical incident. It also seems that this is the perfect solution

the procedures that will allow to file the response to a claim within the

for people harmed due to epidemiological risk and hospital infections.

required – though quite short – term. This is even more important due

The new law is bound to facilitate the unification of forces of homebuyers

to the fact that the legislator has still not regulated a number of issues

in the primary market, in disputes with developers.

and there can be too little time to settle the doubts in the application of

The experience of other European countries shows that the institution of class action lawsuits is conservatively used, but once the collective

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the rules at the last moment. It is therefore worth following the basic solutions introduced by the new law at issue.

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16 | Polish industry When can we refer to a claim as a collective one?

The new regulation which came into force on the 19th July 2010

legal aid or on exempting the party from court costs are not applicable in this case. As a result, all the injured parties will be obliged to pay a court

opens with a definition that clarifies the term of collective proceedings.

fee, regardless of their material status. It seems that such solution will

Collective proceedings are understood as civil proceedings in matters

significantly translate to the functionality of the act, since it is commonly

in which at least 10 people pursue claims of the same kind, which are

known that individuals who have suffered as a result of tort, consumers

based on the same or identical factual grounds. In other words, at least

and people who have claims against the manufacturers on the basis of

10 people should have a claim vis-a-vis the same entity, like a bank,

product liability, generally benefit from the possibility of being exempted

pharmaceutical company, insurer, producer etc.

from court fees. Pursuing such claims for which the statute was in fact

The aim of the new law is the possibility of indemnifying consumers

passed in the first place, namely claims for redress, is indeed possible

who would be allowed to assert their rights in issues concerning claims

in practice – when dealing with cases regulated by the statute at issue –

on the grounds of liability for damage caused by a dangerous product and

only in the context of claims on the basis of liability for damage caused by

on the basis of torts, with the exception of personal rights (an exemplary

dangerous product (article 449 § 1 of the Civil Code). Potential addresse-

catalogue of such rights can be found in article 23 of the Civil Code which

es of claims related to that category of cases are primarily pharmaceutical

stipulates that some of personal rights are, for example, health, freedom,

manufacturers and producers of defective goods.

freedom of conscience etc.)

The fact of issuing collective proceedings does not exclude the possibility of pursuing claims by people who do not belong to the group or those

The announcement (opt-in model) Under the new regime the court shall first of all determine whether the

who decide to withdraw from the group. The latter means that there can be

case can be heard in collective proceedings. If all prescribed premises

parallel proceedings against one entity, for example a bank, one according

are met, the court issues a decision on adjudicating the case in the

to the provisions of the new act of law concerning collective proceedings

collective proceedings, and after such decision has become final, the

and the second according to standard provisions, namely in the situation

court makes an order to announce this fact - in principle - in a prominent

when there is usually only one claimant in the case at issue, despite the

newspapers across the country (exceptionally in a local newspaper or,

fact that in both cases the circumstances at hand will be similar.

occasionally, the court may even fail to give any announcement about the fact at issue). The announcement includes the notice that it is possible

What differentiates collective proceedings from other types of litigation?

for other people to join the group, namely the people whose claims may

Article 24 of the act stipulates that the provisions of the Polish Code

who have not yet been informed about the lawsuit, will have the chance

be covered by the collective claim. Thanks to the latter, other victims

of Civil Procedure shall be applicable in issues not regulated by the new

to join the group, obviously within a term determined by a court (not

law. What merits pointing out are some distinctive features which are

less than one month and not longer than 3 months from the date of the

characteristic for collective proceedings.

announcement). After the term designated by the court has elapsed, it will

Firstly, the new law sets forth that cases in collective proceedings

no longer be possible for additional people to join the group.

shall be heard already in the first instance by the regional court and by the panel of three professional judges. Such solution results from the fact that the legislator perceived the utmost importance of the cases at

Who is the group representative?

Although the minimum number of people in the group that has been

issue and their significance for the protection of subjective rights or the

set forth by the new law is 10, one has to be aware that the group can

interests of the members of the group. There could be a similar reason for

consist of as many as several thousand people –as demonstrated by the

introducing an obligatory attorney/legal counsellor representation for the

experience of other countries.

plaintiff in collective proceedings.

Further derogation from the rules of standard proceedings entails,

The principles governing the relationship between the group and its representative shall be determined in the agreement that the new law does

inter alia, the introduction of additional elements which a class action

not interfere with, leaving it up to the parties to negotiate its provisions in

should include (article 6), or the possibility of directing the parties to

accordance with the principle of freedom of contracts. The representative

mediation at every stage of the litigation.

acts on his own behalf but for all members of the group. The choice of

Another, even more crucial amendment, is breaking with the existing

a person to act as a representative must be approved by all members of

rule that the counsel’s fee cannot depend on the amount awarded to

the group (which follows from the requirement to enclose with the claim

the party (article 5 sets forth the upper limit of the remuneration i.e. the

the consent of all members of the group concerning the representative

counsel’s fee may not exceed 20% of the amount awarded to the plaintiff).

– article 6 paragraph 2), in order to change the representative, however,

What should be also noted is a different regulation in terms of costs

it is sufficient to have the consent of the majority of the group members.

of the proceedings where proportional fee in cases concerning pecuniary

Such regulation may give rise to further problems. The representative is

rights was set in the amount of 2% of the value of the dispute or the value

a party – a plaintiff in procedural terms. The latter means that he or she is

of the claim. It is perceived as an advantageous change, as compared

burdened with a far-reaching responsibility for pleading the case in court.

to the standard amount of 5%, however, the supporters of this new law

The representative is undoubtedly supported by a professional counsel

clearly forget about one important aspect – the provisions on ex officio

since – as has been mentioned above – there is an obligatory attorney/

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Polish industry | 17 legal counsellor representation, however, it is the representative upon whom the law imposes the obligation to comply with prescribed terms; he is responsible for the content of the contract with the counsel and, inter alia, for regulating mutual relations among the group members in the event when some of them withdraw from the group. The representative is also responsible for regulating the internal settlements between members of the group in respect with the issues concerning the deposit, or a failure to pay the latter as well as the obligation of paying the court fees connected, for example, with the press release. The complexities of the procedures related to the initial selection of the people who want to join the group, which is carried out by the representative, as well as his duty to submit to the court a list of people joining the proceedings, raise the risk of limitation for claims, if the representative does not work effectively.

The act also governs the change of the group representative that can be done at any stage of the proceedings, at the request of more than half the members of the group. However, the new law does not regulate the situation of the representative’s possible resignation. What therefore remains controversial is the fact whether it is at all possible for the representative of the group to resign from his function.

The act at issue does not preclude the possibility of setting the

How to defend oneself?

The legislator did not leave the issue of the defendant’s protection

remuneration for the representative, but taking into account the

aside since in the cases at hand the latter can be exposed to a conside-

responsibility that he is burdened with as well as a very wide range

rable ostracism from the side of the public. In order to prevent excessive

of his duties, what raises important questions is the fact whether the

and sometimes unjustified and hasty charges, the legislator foresaw the

representative will agree to hold this function at all and the amount of his

possibility of imposing on the plaintiff (upon the defendant’s demand)

potential remuneration.

the duty of making a deposit to protect the costs of the trial. The deposit shall be made in cash.

What money is involved?

Collective proceedings may take place both in case of non-pecuniary

According to the statute, it is up to the court to determine the amount of the deposit. The court will take into consideration the probable amount

and pecuniary claims. If an asserted claim is of pecuniary character, it

of the costs which the defendant is likely to bear, however the amount of

is necessary to unify (standardise) the amount of claim made by every

the deposit cannot exceed 20% of the value of the dispute. If the plaintiff

member of the group, taking into account the common circumstances

fails to make the deposit within the term set by the court (which shall

of the case. To facilitate the latter issue, the new law introduces the

not be shorter than one month), the court – on the defendant’s motion –

possibility of unifying the amount of monetary claims, which may occur

shall reject collective claim or an appeal.

in subgroups of at least 2 people. If, however, there was a difficulty in

The new law does not regulate the issue whether the plaintiff can be

unifying the amount of monetary claims even in the subgroups (because

exempted from the duty of making the deposit, however, the statute sets

the circumstances of the individual members of the group may vary

forth that the defendant will not be able to demand the deposit when the

considerably), then one can apply the provisions of article 2 paragraph

amount of the claim which was recognized by him is sufficient to protect

3, which states that the subject of a claim may be limited only to the de-

the costs of the trial.

mand of assessing the defendant’s liability. The plaintiff is not required in such circumstances to show his interest in determining the latter.

In such situation, i.e. when in the course of the collective proceedings the court issues ‘merely’ the judgment assessing the defendant’s

Apart from the deposit, the defendant will be also allowed to demand additional indemnity if it turns out, in the course of the trial, that the deposit which was made is not sufficient to protect the costs of the trial.

The defendant has also the right to question the membership of

responsibility, then each member of the group will be able to pursue the

certain people in the group and in the cases concerning monetary claims,

amount of his claim in a separate proceedings.

the burden of proving the membership in the group is upon the claimant.

Article 6 of the Polish Civil Code – ‘the burden of proof is on the person who infers legal consequences from a given fact’ – is obviously applicable and it remains in force. What can be observed is a certain

Prevention is the basic goal What will have to be proved by practice is the issue of how the act

contradiction: on the one hand, the members of the group are still

will be applied and whether the proposed solutions will turn out to be

obliged to prove the extent of the damage and, on the other hand, the

accurate. It should be kept in mind, though, that if the claim form is

law imposes the duty to standardise the claims, having at the same time

served, one shall be ready with the response within a standard term,

regard to the circumstances of the case that are common for all members

namely 14 days and it is definitely insufficient to thoroughly analyse the

of the group. This issue will undoubtedly prove problematic in practice.

act of law.

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18 | Polish industry

Change Management:

Innovation in e-Regulatory Processes Raoul-A. Lorenz LORENZ Life Sciences Group

Every life sciences company needs to innovate - this is the basis upon which they survive and grow. Innovation in life sciences - or research - is frequently associated with research into new active substances, new formulations, or potentially new and innovative strategies for market entry and placement.

Over the last twenty years, there have been quite a number

Regulatory affairs is instrumental in obtaining these authori-

of radical innovations that are perhaps not as publicized as

zations, requiring specific knowledge on national laws and

innovations in new scientific research. These innovations have

regulations, understanding how internal standards or scientific

happened within regulatory affairs, a key component of the

data can be adopted to ensure they comply with the national

overall research and development process within the life scien-

requirements around the world.

ces industry. In many countries, the adage goes “It is illegal to

What started out as a paper copy shop for the life sciences

research, produce, promote or sell any drugs. Unless you have

industry has evolved into a very technical, knowledge-orien-

an authorization that allows you to do so.� Marketing authoriza-

tated and IT-leaning task. Knowledge being key: national

tions are typically obtained by submitting to a regulatory agency

requirements are changing constantly and regulatory affairs

a collection of documents, known as a submission.

needs to be aware of these changes, and also understand what

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19

impact - if any - these changes may have on the existing or

an electronic submission, might look like. Challenges remain,

emerging product portfolio.

however, as every region interprets the standards slightly

IT has also become a major component of regulatory affairs.

Documents, that used to be shipped in paper cartons, are now

differently - but it is a huge step in the right direction.

Tomorrow we are looking towards HL7s (Health Level

digitally transferred between departments or international

Seven) RPS (Regulated Product Submission). Both fairly

subsidiaries. Documents are even transferred digitally to regu-

well publicized efforts have had, and will continue to have, an

latory agencies to obtain the aforementioned authorizations, if

impact not just on how and what we submit to regulatory agen-

an agency is willing and able to accept them electronically.

cies, but it will also have an impact on how documents within

This change has not happened overnight. The first efforts to

organizations are created and released. As technology moves

bring a streamlined digitization process to the scientific docu-

further, the concept of a document may become more blurred,

ment creation and publishing processes began in the eighties,

as data standards begin to replace document standards. This

predominantly in the US with so-called CANDAs (Computer

will have an even more profound impact on how „documents“,

Aided New Drug Applications). These were, however, all

or rather components of a document, are authored, assembled,

individual efforts by pharmaceutical companies and followed

and released in the future. Not only will regulatory affairs

no harmonized process and as a result had a limited impact

have to deal with a completely new technology paradigm,

on creating any efficiencies on industry or indeed on authority

but authors of scientific documents will too. Whilst software

side.

is there to help smoothen the transition, the sheer change

The first standard, supported by a number of then industry leaders as well as a regulatory agency, was the DAMOS (Drug

in philosophy of the definition of a „document“ cannot go completely unnoticed.

Application Methodology on Optical Storage) standard in the

What this means is that much like in other industries,

early nineties. It was the beginning of what was to become a

such as manufacturing, continuous innovation in processes

digital revolution within regulatory affairs, a department that

is vital to remain ahead. Regulatory affairs must understand

perhaps few at the time would have associated with such

that following a particular standard that is valid and works

developments. It began to change entire established document

today will not shield them from innovating and adapting their

processes within companies that had possibly been running for

processes for requirements in the future. The industry in itself

decades. But it did not end there: the digital revolution continu-

does not allow for radical change overnight, and that is good:

es still today and continuously challenges regulatory affairs -

it requires continuous improvement and always ensuring that

industry and agencies - with new technologies that could make

the risks associated with the improvements do not outweigh

the marketing authorization processes even more streamlined.

the benefits. As a result, regulatory affairs will have to become

Once technology became a fact of life within regulatory affairs,

used to iterative improvements, or step-by-step improvements,

regulatory departments not only had to deal with change

a concept that has been embraced by many software develo-

management for scientific regulatory requirements, they also

pers as well, as they manage ever more complex and growing

had to deal with changes in electronic regulatory requirements.

code. This helps to mitigate risk, and ensures that when

Both continue to evolve to this day, and do not look to cede to

properly managed, all stakeholders can be brought on board.

the comfort of a status quo.

Since DAMOS, there have been numerous efforts to further

The bottom line is that digital changes in regulatory affairs (or e-Regulatory Affairs) has the goal to improve, not worsen,

standardization and adopting evolving technologies: whether

the overall process. Whilst there may be obstacles ahead,

SEDAMM (Soumission Electronique des Dossiers d’Autorisa-

those ignoring these changes may well find themselves left

tion de Mise sur le Marche), the EU MANSEV (Market Authori-

behind in the near future. Those embracing them will become

zation by Network Submission and Evaluation) initiative, or the

leaders in their field and help further their entire organization.

FDA eNDA project - to name but a few. It was the FDA eNDA

The changes taking place have the one goal to help bring

project that kick-started a broad acceptance by both industry

better and safer medicines to patients faster. They are, of

and agencies around the world that electronic was coming, like

course, also a source of higher returns of investment for

it or not.

those embracing the changes, and continuously adapting to

Today we look towards standards such as the ICH (Interna-

them as well, once the learning curve has been climbed. An

tional Conference on Harmonization) CTD (Common Technical

organization that braces itself for continuous innovation and

Document) and eCTD standards. This standard has helped to

change will also find it easier to adapt in the future, lowering

bring on board many regulatory regions and created a general

the learning curve and thus generating higher returns more

cross-boarder consensus on what a submission, or indeed

quickly.

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20 | Polish industry

How to extend patent protection for a medicinal product?

Magdalena Tagowska PATPOL – Patent and Design Department

SPC can be defined as a protection right granted in the European Union member states for medicinal and plant protection products based on the following EU regulations: Regulation (EC) No 469/2009 of the European Parliament and of

Provisions of Regulation 469/2009

In the preamble part of this regulations the legislator has specified the reasons for its issuance. In addition to the above mentioned time reduction of the effective patent protection for medicinal products, it was considered necessary

the Council of 6 May 2009 concerning the supplementary protection

to introduce said regulation at the EU level due to the following reasons:

certificate for medicinal products, which has replaced Council Regulation

• pharmaceutical research plays a decisive role in the continuing

(EEC) No 1768/92, and Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products.

It is a unique form of protection, whose concept is completely new

improvement in public health; • medicinal products, especially those that are the result of long, costly research will not be developed in the EU unless favourable protection conditions are ensured;

in the Polish patent law. It was introduced in the Act of 30 June 2000 on

• the reduced period of effective protection is in the case of medicine

Industrial Property Law (Journal of Laws, No 119, item 1117, 2003 with

development equivalent to a complete lack of protection; such a

later amendments) in 2002 and became a part of the Polish legal system

situation penalizes pharmaceutical research and may result in a risk

after Poland’s accession to the European Union in 2004.

that research centres located in the member states will be moved to

The supplementary protection certificate was introduced for the above mentioned products because the time of effective patent protection of

countries offering better protection; • a situation in which different solutions with respect to protection

these products is shorter, due to a fact that medicinal and plant protection

of medicinal products would be developed by each member state

products cannot be introduced on the market directly. They can be placed

separately could be damaging to the common market, as it would

on the market after the marketing authorization is obtained. In order to

impair free movement of goods.

obtain the marketing authorization a time-consuming research and long

Further in the preamble the legislator states that the provision of a sup-

administrative procedures are required, which to a large extent limit the

plementary protection certificate granted, under the same conditions, by

time of the monopoly for using the invention. Therefore the supplementary

every member state at the request of the holder of a national or European

protection certificate compensates in a way for the lost time of patent

patent relating to a medicinal product for which marketing authorization

protection.

has been granted, would prevent all of the above dangers.

Introduction of the supplementary protection certificate has enforced

This regulation has established that duration of the protection granted

significantly protection of medicinal and plant protection products, by

by the SPC should provide adequate and effective protection for a medicinal

awarding additional protection, which begins after patent expires. This extra

product. It was acknowledged that this condition would be met if the patent

protection lasts up to 5 years. For the medicinal products, the protection

and SPC holder could enjoy an overall maximum of 15 years of exclusivity

resulting from the SPC can be extended even further under specific

from the time the medicinal product in question first obtains authorization

conditions for additional 6 months. In reality the grant of the supplementary

to be placed on the market in the EU. While working on provisions of this

protection certificate is limited in many ways and the protection it confers

regulations the Council took under consideration not only the interest of the

does not reflect a direct extension of patent protection.

right holder, who has developed the innovative medicine, but also the public

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Polish industry | 21 Patent protection guarantees 20 years of market exclusivity for a medicinal product covered by a patent starting from the filing date of the patent application. The only way to extend patent protection for a medicinal product is to apply for the grant of a Supplementary Protection Certificate (SPC).

interest, as the SPC will promote the development of the pharmaceutical

authorized before the expiry of the supplementary protection certificate. The

industry. Also in the public interest the duration of the SPC was limited to

following question was raised with respect to this provision. Would the SPC

a maximum of 5 years. Moreover, the scope of protection was also limited,

protect only the product in the same pharmaceutical form as that for which

as after the patent expiration the SPC does not cover the entire invention

the marketing authorization was issued? This question was answered in

covered by the patent but only the subject matter that is closely related with

1999 by the Court of Justice of the European Union (ECJ) in the judgment

the medicinal product for which the marketing authorization was obtained.

in the case of Farmitalia Carlo Erba Sri. This company was the holder of a patent granted in Germany for idarubicin, a method of manufacture thereof

Definitions

and its pharmaceutical composition. The said company also obtained a

In the regulation several definitions were introduced, which are crucial

marketing authorization for a medicinal product under the name “Zavedos”,

for the interpretation of this regulation. The first term used in the regulation

in which the active ingredient was idarubicin hydrochloride also covered

is “medicinal product”. According to the regulation a medicinal product

by the basic patent. Based on that patent and the patent holder’s request the

means “any substance or combination of substances presented for treating

German Patent Office has issued a supplementary protection certificate for

or preventing disease in human beings or animals and any substance or

“The medicament Zavedos containing as its active ingredient idarubicin

combination of substances which may be administered to human beings

hydrochloride”, even though Farmitalia sought protection for “Idarubicin and

or animals with a view to making a medical diagnosis or to restoring,

salt thereof including idarubicin hydrochloride”. Farmitalia began appeal

correcting or modifying physiological functions in humans or in animals.”

proceedings before the Federal Patent Court in order to obtain a certificate

Art. 1 of the regulation also provides a definition of “a product” in the

for “Idarubicin and salts thereof including idarubicin hydrochloride” or

meaning of an active ingredient or a combination of active ingredients,

alternatively “Idarubicin and idarubicin hydrochloride”. However, the

as well as a definition of “a basic patent”, i.e. a patent which protects the

court has rejected Farmitalia’s request. The patent holder has appealed the

product, a manufacturing process of the product or use of the product, and

decision before the Highest Federal Court, which has directed questions for

which is designated by its holder for the purpose of the grant procedure of

preliminary ruling to the ECJ. The ECJ stated that the SPC can cover not only

the supplementary protection certificate. It is important that the basic patent

the form of a product directly indicated in the marketing authorization, but

does not have to be granted directly for a product as such. It is possible to

also other product forms (for example salts and esters), as long as they are

formulate the scope of protection in a popular for pharmaceutical inventions

protected by the basic patent. The ECJ has also indicated that the protection

format of patent claims, i.e. as first and second medical use claims.

provided by the SPC limited to the product for which marketing authorization was issued would be easy to circumvent by using in the medicinal product

Subject matter of the supplementary protection certificate

other form of the active ingredient indicated in the basic patent.

Therefore, currently the Polish Patent Office as a rule grants supple-

According to Art. 2 of the regulation protection conferred by the SPC

mentary protection certificate for a compound identified by its INN and

can extend to any product, which is covered by a patent in the territory of a

salts and esters thereof, provided that they constitute the essence of the

member state and subject to administrative procedure resulting in issuan-

basic patent and that they exhibit the same therapeutic properties as the

ce of a marketing authorization, before it can be placed on the market. The

product for which the marketing authorization was issued.

regulation even specifies the administrative procedure as that established in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products

Conditions for obtaining the certificate and its duration Conditions for obtaining the supplementary protection certificate were

for human use or Directive 2001/82/EC of the European Parliament and

mentioned in Art. 3 of the regulation. In this provision it is indicated that

of the Council of 6 November 2001 on the Community code relating to

the SPC can be granted in a member state in which the SPC application

veterinary medicinal products.

is submitted, provided that on the date of said application the following

How is the scope of protection resulting from the SPC defined?

requirements are jointly fulfilled:

According to Art. 4 of the regulation, the protection conferred by the SPC

• the product is protected by a basic patent in force,

corresponds to the patent protection, however it is limited only to the product

• a valid authorisation to place the product on the market as a medicinal

covered by the marketing authorisation for the corresponding medicinal

product has been granted in accordance with the directives indicated in

product and to any use of the product as a medicinal product that has been

Art. 2 of the regulation,

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22 | Polish industry • the authorisation mentioned above is the first authorisation to place the product on the market as a medicinal product (i.e. there was no earlier marketing authorization for the product of interest), and • the product has not already been a subject of the supplementary protection certificate.

All of these requirements are evaluated with respect to a country, in which the SPC application is filed. It means that the product must be protected by a valid patent in said country and that the suitable marketing authorization has been issued there.

The duration of the SPC was determined by the provision of Art. 13 of the regulation. The supplementary protection certificate takes effect at the end of the lawful term of the basic patent for a period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorization to place the product on the market reduced by 5 years. The second limitation regarding the duration of the SPC specified in Art. 13 is that it the duration of the supplementary protection certificate cannot exceed 5 years from the date on which it becomes effective. as the basic patent (for example, an agreement establishing joint ownership

Entitlement to the SPC

of the supplementary protection certificate rights).

The supplementary protection certificate can be granted to the patent holder or to his legal successor, as mentioned in Art. 6 of the regulation.

The patent referred to above is the basic patent, which covers the product

Expiry and invalidity of the certificate The supplementary protection certificate can expire at the end of the

for which the marketing authorization as a medicinal product was issued.

period for which it was issued, if the certificate holder surrenders it, if the

While only one SPC can be granted based on one basic patent, it is

annual fee for the SPC protection is not paid in time or if the marketing

possible that one and the same medicinal product is protected by several

authorization or authorizations are withdrawn (Art. 14 of the regulation).

patents issued to several different patent holders. Such a situation was

The Patent Office may take a decision on the SPC expiry either of its own

described in the ECJ judgment in the case of Biogen, Inc. v. Smithkline

motion or at the request of the third party.

Beecham Biologicals SA in 1997. The Court of Justice stated that where a

Art. 15(1) of the regulations also anticipates a possibility to invalidate

medicinal product is covered by several basic patents, the regulation does

the supplementary protection certificate in the following situations: if the

not preclude the grant of a supplementary protection certificate to each

SPC was granted contrary to the provisions (i.e. the requirements set in Art.

holder of a basic patent. At the same time, it was indicated that in case when

3 are not fulfilled); or if the basic patent expired before the term for which it

a marketing authorization and a basic patent are held by different persons

was granted; or the basic patent was revoked or limited to the extent that the

and the patent holder is unable to provide a copy of that authorization, the

product for which the certificate was granted would no longer be protected

SPC application cannot be refused based only on the fact that such a copy

by the claims of the basic patent; or if after basic patent expiry there exist

of marketing authorization was not submitted to the Patent Office.

grounds, which would justify invalidation as well as the limitation of the patent claims. It is very important that any person can submit an application

Effects of the Supplementary Protection Certificate grant The effects of the supplementary protection certificate grant are

or bring an action for declaration of invalidity of the SPC and it is not necessary to evidence one’s legal interest (Art. 15(2) the regulation).

If the supplementary protection certificate expires for a reason other

specified in Art. 5 of the regulation. With a provisions of Art. 4, the scope

than expiration of the term (for example through a renouncement of the

of protection conferred by the supplementary protection certificate must be

supplementary protection certificate by its holder) or it is invalidated, the

comprised within the scope of protection of the basic patent. Moreover, the

Patent Office publishes this information (Art. 17 of the regulation).

supplementary protection certificate confers the same rights, limitations and obligations as the basic patent. As a consequence of the SPC grant an exclusive right is created to exploit, dispose, as well as to licence the subject of the certificate. This monopoly is also subject to the same

The product as defined in the basic patent vs. a product named in the marketing authorization Sometimes it might be difficult to determine whether or not the product

limitations as the patent right, in particular with respect to its duration,

mentioned in the basic patent corresponds to the product defined in the

territory and potential use. The product protected by the SPC can be

marketing authorization. In case of patent specifications in the field of

subjected to a compulsory license. Moreover, the actions, which do not

pharmacy, the active ingredients are defined by their chemical names or

infringe the basic patent do not infringe the right conferred by the SPC (for

structural formulas, whereas the marketing authorizations make use of

example, preparation for registration and marketing of a generic drug). The

the simplified names of active substances, i.e. the INN names. In certain

subject-matter of the certificate can be also a subject of the same contracts

cases it will be required that the patent holder provides all the necessary

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Polish industry | 23 excludes a possibility for obtaining supplementary protection certificate for products obtained by a new method, regardless of the fact that effective patent protection period will be limited by issuance of a separate marketing authorization.

The judgment in the case of Massachusetts Institute of Technology (MIT) will have even more significant impact for examination of supplementary protection certificate applications, because it regulates an issue of a combination of an active ingredient with an auxiliary substance, which plays a particular role in the combination. MIT is a holder of the German patent for an intracranial implant for controlled release of a cytotoxic agent called carmustine, which is intended for treatment of brain tumours.

The effect of delayed release was achieved due to the application of a biodegradable polymer called “polifeprosan”. MIT applied for issuance of supplementary protection certificate after receiving a marketing authorization on the territory of Germany for this combination under the name of Gliadel. The German Patent Office refused granting the SPC, in contrast to the Patent Offices of Great Britain and France, who granted the SPC for information in order to confirm that the same compound is the product of

said product. The ECJ has sustained the decision of the German Patent

interest in the basic patent and in the marketing authorization.

Office and indicated that the concept of combination of active ingredients

In the guidelines provided by the Polish Patent Office the specific

of a medicinal product does not include a combination of two substances,

examples are presented, which show whether or not the basic patent will

only one of which has therapeutic effects of its own for a specific

be considered a sufficient basis for the SPC grant for a particular medicinal

indication, the other rendering only a delivery of the active ingredient. This

product named in the marketing authorization. For example, when a basic

judgment in a significant degree reduces a possibility for obtaining the

patent makes a reference to a pharmaceutical composition comprising

supplementary protection certificate for a novel technical solution in the

compound X in combination with some auxiliary substances, it should

field of pharmaceutics, which are directed to novel drug delivery forms, or

be understood that it is a sufficient basis for the SPC application for a

second or further medicinal uses.

compound X. Nevertheless, whenever the basic patent is directed to two active substances X and Y, the basic patent will not be sufficient for the grant of the supplementary protection certificate for a product consisting of substance X alone.

Extension of the duration of the SPC Under certain conditions it is possible to extend the duration of the SPC by six months. The conditions that need to be fulfilled in order to

The following ECJ judgments are of particular interest for the

extend the duration of the SPC are named in Article 36 of Regulation

examination of the SPC applications: a judgment of 2001 in the case of

(EC) No 1901/2006 of the European Parliament and of the Council of 12

BASF v. Bureau voor de Industriële Eigendom (BIE), as well as a judgment

December 2006 on medicinal products for paediatric use. The extension

of 2006 in the case of Massachusetts Institute of Technology. The first one

of the duration of the supplementary protection certificate is possible after

relates to Regulation 1610/96 concerning the creation of a supplementary

clinical trials on paediatric population are completed in accordance with

protection certificate for plant protection products, however it certainly

the approved paediatric investigation. It should be emphasized that such

may be applied in the case of the medicinal products. BASF was a holder

an extension of the SPC duration is also possible even if the completed

of a Dutch patent for a method of manufacturing of an active ingredient,

approved investigation plan did not result in marketing authorization with a

which was used in a pesticide called “Pyramin DF”. BASF also obtained a

paediatric indication. However the six month extension of the SPC duration

marketing authorization for this pesticide in the territory of the Netherlands.

is possible only if the medicinal product was authorised to be placed on

However, the supplementary protection certificate was not granted for

the market in all of the EU member states.

the active ingredient, because 20 years before obtaining a marketing authorization for “Pyramin DF”, BASF obtained an authorization to place

Conclusion

on the market in the Netherlands a product named “Pyramin”, in which a

The supplementary protection certificate might turn out to be an

degree of contamination with the inactive isomer was significantly greater

effective tool of industrial property protection for pharmaceutical industry.

than in case of product “Pyramin DF.” The Patent Office indicated that

However, the success of this EU regulation will be determined by the

both of these pesticides differ only in the content of the impurities, which

practice established by the Patent Offices throughout the EU. In view of the

in view of the regulation cannot be considered as a product, whereas

ECJ judgment in the case of Massachusetts Institute of Technology limiting

both marketing authorizations relate to the same product. The ECJ has

the scope of protection of the supplementary protection certificate to the

shared the view of the Patent Office and stated that products which differ

literal interpretation of the regulation, might cause that the supplementary

only in the proportion of the active chemical compound to the impurity

protection certificate will not give the medicinal products the level of

they contain, should be regarded as the same product. This judgment

protection excepted by their manufacturers.

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24 | Polish industry

Nycomed The net turnover for 2009 amounted to EUR 3.2 billion. Nycomed owns 19 plants manufacturing medicinal products in 13 countries and holds the 28th place amongst the largest pharmaceutical companies in the world as well as the 16th place in the international market of OTC products.

Beginnings of Nycomed in Poland The history of the pharmaceutical plant in Łyszkowice in the Łódź province dates back to the mid 90s of the last century. In autumn of 1995, representatives of the German company Byk Gulden Lomberg GmbH paid their first visit to the Łowickie Zakłady Farmaceutyczne /

which in the 1980s were partially modernised and retrofitted within the ministerial investment scheme entitled “Production of Calcium Salt”.

The new manufacturing plant in Łyszkowice In August 1996, Byk Gulden Lomberg was selected to be the strategic

Łowicz Pharmaceutical Plant/ “Polfa” in Łyszkowice. “Polfa” was mainly

partner for “Polfa” in Łyszkowice within the scope of the company’s priva-

located in 19th century production facilities of the former sugar plant,

tization. Simultaneously, a decision was made concerning construction of

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Polish industry | 25

worldwide a new plant just next to the old facility. The designing stage of the modern

from Germany was the general contractor. Simultaneously, a long and

plant took place between 1997-1999. The final design was prepared by

complicated process was initiated which concerned the preparation and

“Carpus & Partner”, a German company which for the purpose of this

transport of equipment from other European Byk plants to Łyszkowice.

project cooperated with the Łódź-based design company “Biprowłók”.

A large part of the equipment for the new plant, especially for manufactu-

In December 1998, Byk Gulden Lomberg signed an agreement with the

ring liquid forms, was ordered as brand new.

State Treasury on the basis of which Byk established a new joint-venture

Main construction works were completed in the summer of 2000.

entity with “Polfa” under the name “Byk Mazovia Sp. z o.o.”. One of the

At this time the machines and equipment were introduced to the

obligations of the incorporation agreement was the construction of a new

production areas. This process was only completed in 2001 when all

plant. Thus, the arrangements made between both companies and State

equipment was transferred from the facility of the former “Polfa”. In

Treasury could be quickly implemented, based on the prepared design.

October 2000 a handover report of the new plant was signed, and on

Upon completion of the preparatory stage and obtaining the applica-

May 28, 2001 an official opening ceremony was held with the attendance

ble permits, the construction of the new plant “ZF Byk Pharma” began

of the representatives of central administration bodies, provincial and

in April 1999. This was a typical greenfield investment. “DYWIDAG”

regional officials as well as the management board of Byk. A few months

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26 | Polish industry completed the facility in Łyszkowice was approved as a place of manufacture for the German market.

Further development The years 2002-2003 were a period of establishing the strategy of operation and further development of the plant.

Utilization of the entire production capacity of the plant was the chief objective. This aim was completed not only by intensifying production and launching new products onto the Polish market as well as for the ALTANA corporation, but also by acquiring and processing orders for contract manufacturing of drugs. In the years 2003-2007, an intense search for partners and long-term negotiations resulted in establishing a number of interesting partnerships with companies such as: Solvay, Rosell Institute, Merck, Schwarz Pharma (currently UCB) and A. Tiefenbacher. As a result, at the end of 2008, the contract manufacturing activity constituted more than a half of the entire production volume of the plant.

New owner prior to the official opening, the plant underwent the first pharma-

As a result of acquiring ALTANA Pharma AG by Nycomed in 2007,

ceutical inspection and was approved on April 23, 2001 as a place

the plant in Łyszkowice was placed in the first five of the competence

of manufacturing medicinal products for the Polish market. Thus the

centres, specialising in production of OTC medicinal products amongst

manufacturing activity was established in Poland by “Byk Pharma Sp.

the 19 plants belonging to Nycomed in the world. The main criteria for

z o.o.”. In connection to the change of name of the corporation, the Polish

the selection were the current main production profile, experience and

daughter company changed its name to “ZF ALTANA Pharma Sp. z o.o.”

knowledge of the employees as well as great conditions of manufacture.

in 2002. It shall be mentioned that also in 2002 a significant expansion

Since the beginning of 2009 a very important project has been

of the plant was finished within the scope of which quality control and

implemented concerning the transfer of production to Łyszkowice

product development laboratories were handed over for use. The capital

from other manufacturing plants of Nycomed in Finland and Denmark.

expenditure totalled approximately PLN 150 million.

Consequently, the production volume of the plant in Łyszkowice shall increase by ca. 30% in 2010-2011. The products manufactured shall be

Production for the Polish and foreign markets

exported to the CIS and Scandinavian markets.

Initially, the offer of products manufactured by the plant was not very wide and included mainly the products of the former “Polfa”/“Byk Mazovia”, though from the very beginning the Łyszkowice

Quality and performance In order to take on the challenges of the dynamic increase of the

plant manufactured some of the Byk Gulden drugs which were

production volume as well as extension of the product range, in 2008

most popular in the Polish market. At that time, the export activity

the plant began introducing world class manufacturing principles

was limited merely to manufacturing mouthwashes for the Italian

into its policy. Constant improvement of production processes while

market as well as dietary supplements for the Spanish market. The

guaranteeing high quality of products shall strengthen the position of the

range of manufactured products was gradually extended. The most

Łyszkowice plant amongst other manufacturing plants of Nycomed, as

important achievement was the quick launching of production of

well as its position as a contract manufacturer.

two OTC medicinal products, one of which was especially popular in Germany. In appreciation of this achievement, the management of ALTANA Pharma decided to turn the plant in Łyszkowice into

Technologies The plant has two production departments (non-sterile liquid and

the centre of manufacturing of this product not only for the German

solid forms), a high bay warehouse, quality and product development

market but also for other European markets and Arab countries.

laboratories as well as a power facility.

In order to do that, in 2002 the plant was submitted to undergo

Liquid products are filled into glass and plastic bottles with the

certification by the German Pharmaceutical Supervision Office

volume of 25-1000 ml and are packed on 4 production lines. Tablets

from Tübingen. The 5-day audit conducted in January 2003 by two

(including film-coated tablets) are manufactured at the department of

inspectors from Germany, with the attendance of a manufacturing

solid forms and packed into blisters at 3 blistering/packing lines or

inspector acting on behalf of the Main Pharmaceutical Inspector,

into plastic and glass containers at 2 filling/packing lines; powdered

was a complete success. Several weeks after the inspection was

medicinal products are packed into sachets.

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Polski Holding Farmaceutyczny is selling Polfa Tarchomin The privatisation of Polfa Warszawa will be repeated Robert Miller

On July 27th, PHF sent out invitations to purchase Polfa Tarchomin. During the course of the privatisation of Polfa Warszawa a decision was taken to end it, so far this has not been settled.

Polski Holding Farmaceutyczny privatised Polfa Pabianice in February

the spent five years (2002-2007) as deputy director for economics and

2010. Then it began the process of privatising Polfa Warszawa, and

finances at the Pomnik Institute – Centrum Zdrowia Dziecka (Child Health

the sale of Polfa Tarchomin, the last of the three companies in the PHF

Centre), where she reorganised and significantly increased the budget.

portfolio, is currently under way.

Since 2008 a member of the management board of Tarchomińskie Zakłady

On July 27th 2010 PHF sent ninety two carefully selected investors from all over the world invitations to purchase Tarchomińskie Zakłady Farmaceutyczne Polfa S.A. “In sending out the invitations to buy the Tarchomińskie Zakłady we

Farmaceutyczne Polfa, and since July 26th 2010 the Chairwoman of its Management Board.

Andrzej Barna, Member of the Management Board of Tarchomińskice Zakłady Farmaceutyczneh Polfa S.A. graduated from Finances and

chose the major players on the pharmaceutical markets on every content,”

Statistics Department of Warsaw School of Economics. He is an expert in

said Artur Woźniak, chairman of Polski Holding Farmaceutyczny.

investment risk assessment, organising and managing merger and takeover

The invited investors will be able to submit initial purchase offers until

processes, and finance restructuring. Until 1995 he was employed with the

September 30th 2010. “We estimate that we will be able to shortlist bidders

consultants Access Ltd. Between 1995 and 1996 he was employed in Opti-

at the end of the year,” added Artur Woźniak.

mus S.A. as strategic Planning Director. In 1996 he took on the position of

The chairman also confirmed that invitations had only been sent to branch investors.

Development Director and then director of the finance department in the E Kwiatkowskiego investment fund. From 1999 to 2005 he was employed

by PKN Orlen as Director of the Capital Investments Office. Employed from

Changes in the management of Polfy Tarchomin The issuing of the invitations coincided with changes in the management of Polfa Tarchomin. Since June 9th the chairwoman of

2005-2008 in Polimex – initially as Deputy Director of Finances, and then Director of Mergers and Takeovers. During 2009-2010 he worked in WSiP as Director for Capital Group Development.

Polfa Tarchomin’s management board had been Mirosława Dawidziuk, a representative of Polski Holding Farmaceutyczny. On July 26 this year a new board memberships was established for the company. The changes

Warsaw without a settlement Meanwhile Polski Holding Farmaceutyczny also issued information

affect the position of Chair of the Board of Management, who is now Halina

that a decision had been made with regard to the sale of Polfa Warszawa.

Lachowska, and the composition of the Board of Management, which has

It has been decided to end the privatisation process without a settlement.

been joined by Andrzej Barna.

Here are their brief biographies: Halina Lachowska, Chairwoman of the Board of Management of Tar-

“We will recommence the sale procedure. We estimate that between the 3rd and 4th quarter of this year we will send out invitations to potential investors,” said Artur Woźniak.

chomińskie Zakłady Farmaceutyczne „Polfa” S.A. is a specialist in the field

Privatisation had been under way since October 28th, when the

of health service finances. She completed doctoral studies at the University

invitations to buy Polfa Warszawa were sent out. This however led to no

of Economics in Kraków. Specialist and economic adviser at the Health

satisfactory outcome for a Polski Holding Farmaceutyczny.

Ministry from 1994-1996 and 1999-2000. Director of the Department

”We took the decision to end the privatisation proceedings without an

of Budgets, Finances and Investments at the Health Ministry, where she

outcome because we could not agree on a sale faced with the offers we

managed the budget and supervised the ministry’s long-term investments.

had received from. Polfa Warszawa must be privatised under conditions

She has a wealth of experience in managing health service bodies - from

which satisfy the employees and the Treasury,” explained the head of PHF.

1996-1999 she was director of the Health Care Centre in Olkusz, and

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Source: PHF

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28 | Polish industry

Sanfarm

Sp. z o.o.

Sanfarm is a modern pharmaceutical contract manufacturer which operates in “Euro-Park Wisłosan” Tarnobrzeg Special Economic Zone within Nowa Dęba sub-zone. The company is included in the Capital Group of Polfa Warszawa S.A. It is equipped in accordance with GMP and FDA highest world norms

Sanfarm Sp. z o. o. is the youngest pharmaceutical industry plant in

blisters and plastic containers, modern high storage department and well

Podkarpacie which carries out contract manufacturing of pharmaceutical

equipped laboratory base.

products. The Company was founded in 1999 by Polfa Warszawa S.A. -

The Tablets and Dragées Departments are fitted with all kinds of sys-

the sole Company owner. Since then, the modern pharmaceutical plant

tems suitable in pharmacy as well as Western technological equipment

has been developed which fulfills the highest world norms. Sanfarm

imported from England, Germany, Italy, Belgium and other countries.

is the biggest investment in the territory of the “Euro-Park Wisłosan” Tarnobrzeg Special Economic Zone.

Manufacture range

The manufacture was designed and built in accordance with GMP

Most production are medicines produced on behalf of Polfa War-

and FDA standards binding in the European Union and the United States

szawa S.A.. Among medicines manufactured by the Company are such

of America which guarantees the highest quality of manufactured pro-

famous examples as: Acard ®, Allertec ® WZF, Vitaminum B compositum,

ducts. Upon the completion of its construction in 2005, the modern plant

Lipancrea® 8000.

was put into operation, possessing, among others, tablets and dragées departments, packaging department equipped with lines packaging in

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Manufacturing of medicines in Sanfarm is carried out in compliance with up-to-date and at the same time typical pharmaceutical techno-

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Polish industry | 29

– the youngest pharmaceutical industry plant in Podkarpacie Region with total surface area of almost 17,000m2.

Its manufacturing capacity amounts annually to about 2.5 bln tablets, coated tablets and capsules.

All solid forms of Polfa Warszawa S.A. medicines are currently manufactured in Sanfarm.

logies used for producing solid forms of medicines. The most modern

• Mechanical mixing

technical and technological achievements were applied in the manufac-

• Tabletting / Encapsulating

ture. The production is ecologically very pure and almost waste-free.

• Film / sugar coating of tablets

Sanfarm acts on grounds of the principle of a balanced development

• Packing of tablets in blisters / plastic containers

where business successes go hand in hand with social responsibility.

• Analyses of materials and products

We belong to the group of companies which understand and accept

• Warehousing

their ecological obligations and take full responsibility for the way they influence the environment.

Manufacturing in Sanfarm is carried out in the following technologi-

The whole manufacture cycle in Sanfarm is possible to be carried out in the conditions of lowered humidity (down to 25% of relative humidity).

cal areas:

Sanfarm possesses thoroughly equipped high tech laboratories:

• Weighing and sieving of materials

• Analytical

• Mechanical and fluidal granulation

• Microbiological

• Tray- and fluidal drying

• In-Process Control laboratory

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30 | Polish polski przemysł industry

Production capacity of the manufacture amounts annually to over 2.5 bln tablets, coated tablets and capsules. The company strategy and message is to offer the highest quality services on contract manufacturing of medicines at the lowest costs.

Currently, the Company is the second employer in Nowa Dęba regarding the number of employees.

More than a half of the staff, average age of 36, hold higher education diplomas. Despite the young age, Sanfarm staff have remarkable professional experience which, when accompanied with eagerness for

Contract services Sanfarm core competences are contract manufacturing services in the scope of manufacturing bulk product, packaging, storing of popular

new challenges, enables implementing manufacturing of new products, as well as making regular improvements in technology of so far manufactured medicines.

medicinal products and dietary supplements as well as carrying out analytical and microbiological tests on assignment basis.

The Company is a contract manufacturer of tablets and other solid

Neighbourhood Sanfarm is a young company which quickly achieved organization

forms of medicines which are produced at competitive prices - accompa-

capacity and so it can be described as starting its maturity phase.

nied with meeting requirements of individual contractors.

Almost since the very beginning the Company gets passionately involved in social milieu and the neighbourhood life.

Employees In Sanfarm we believe that market success can only be reached with full support and commitment of our employees. Sanfarm provides its employees with the best working conditions and professional development opportunities. Hence the Company’s consistent human

We support local initiatives, build the Company’s image and trust of customers which in our development plans allows for taking into consideration both our values and needs of the neighbourhood.

While still in the process of construction, the Company as a modern enterprise with good prospects for the future was honoured by the

resources policy - supporting the employees in their development and

authorities of Tarnobrzeg Special Economic Zone with the title “Inno-

self-improvement with the assumption that the development of the

vation 2001” and in September 2007 - with the title of the Nowa Dęba

Company is impossible without the staff development. Sanfarm staff are

sub-zone Leader.

talented, ambitious people, regularly empowered to increase their role and influence on a way the Company operates.

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conferences, fairs, training | 31

The second Congress of the World of Pharmaceutical Industry is already behind us. It was held from June 10 to 11, 2010, in “Nowy Dwór” Wellness & SPA Hotel in Świlcza near Rzeszów and its Honorary Host was Sanofi-Aventis Sp. z o.o. – Producer and Distributor of Medicines seated Rzeszów.

This year’s Congress was the continuation of the last year’s edition whose Honorary Host was Zakład Farmaceutyczny Polfa Łódź S.A. [Pharmaceutical Company].

The participants of the Congress were research and development directors, maintenance specialists, technologists, automation engineers, heads of production, control and quality departments and heads of logistics and supply departments in pharmaceutical enterprises – in total: more than 160 people representing leading pharmaceutical enterprises and other companies operating in the industry.

The high level of knowledge presented at the Congress was due to the experts from pharmaceutical companies, institutions and organisations related to the pharmaceutical industry.

The thematic scope of the programme of the Congress included all the main pharmaceutical production stages, from the supply of raw materials for production to the storage and forwarding of the ready products.

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32 | conferences, fairs, trainig

The topics discussed in detail included:

• risk assessment tools for the evaluation of validation scope and effort,

• the properties of Astaxanthin,

• integrated approach from validation of scada systems,

• the development of analytical methods to determine API,

• the certification and release of series of medical products,

• newer constructions of pelleting machines – technical and

• adverse drug reactions,

technological aspects, • eCDT – documents attached to an application for a marketing authorisation of a medicinal product, the requirements of the Office for Registration of Medical Products (URPL), the problems of pharmaceutical companies and ways of solving them, • the current status of eCTD, the situation in Poland and in the world. How to prepare well to the purchase of an eCTD generating system, what factors to take into account when choosing the system? The future of the eCTD format, • management and the quality system, • ensuring quality – documents,

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• the role of a qualified person in suspending a series, • the labelling of medical products – the applicable law and guidelines, • the regulation on medical product labelling. Labelling in the Braille system. Graphic design. The clarity of labels from the perspective of patients, • supporting logistics in pharmacy in accordance with GS1 global standards – National Health Products Database (KB POZ), • the patenting of pharmaceutics, • the automatisation of warehousing in the pharmaceutical industry as a way of saving storage space and time.

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conferences, fairs, training | 33

The Congress was held under the honorary auspices of: the Ministry of Economy, the “FARMACJA POLSKA” Chamber of Commerce, the National Institute of Public Health - National Institute of Hygiene (NIZP-PZH), the Marshal of the Podkarpackie Province, the President of the City of Rzeszów.

The patronage over the content of the Congress was held by: the Pharmaceutical Institute (IF), the Institute of Logistics and Warehousing (ILIM), the National Medicines Institute (NIL).

The final attraction of the Congress included visiting selected production departments of Sanofi-Aventis Sp. z o.o.

- Producer and Distributor of Medicines seated in Rzeszów.

As soon as today we would like to invite you to take part in the next year’s – third – edition of the congress.

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34 | production

Imaging diagnostics market in Poland EU funds – a key stimulus to market development Agnieszka Stawarska Pharmaceutical market analyst PMR Publications

Since in Poland the EU funding is a key source of financing to purchase imaging diagnostic equipment, the public sector – whose purchases are largely co-funded by the EU – has not been affected by the crisis and a high euro exchange rate which in turn had a slightly negative impact on procurements for the equipment in the private sector in 2009.

OPI&E: Priority 12 for healthcare The Operational Programme Infrastructure and Envi-

Since the beginning of the program one contest has been

ronment (OPI&E) for 2007-2013 is co-funded from the

settled based on the Action 12.2. As a result, following

Cohesion Fund and the European Regional Development

the lists approved by the Minister of Health in November

Fund. The OPI&E supports six economy sectors including

and December 2009 as well as in April 2010, over a dozen

health protection. Healthcare establishments are suppor-

healthcare units received funding for purchasing imaging

ted based on Priority 12 (Health security and improving

diagnostic equipment. For instance, the Gliwice Branch of the

the efficiency of the healthcare system), Actions 12.1

Oncology Centre – M. Sklodowska-Curie Institute in Warsaw

(Development of the medical rescue systems) and 12.2

has received a contribution of PLN 8.5m (€2.1m) for the

(Investment in healthcare infrastructure at the supra-re-

project ‘Improving the quality and effectiveness of cancer

gional level). The latter provides funding for the imaging

diagnostics in Poland by exchanging the imaging equipment

equipment.

in nuclear medicine’. In turn, the Cardinal Wyszynski Cardio-

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35

logy Institute in Warsaw was granted PLN 7.7m (€1.9m) for

Programme allotted PLN 1.3m (€0.3m) for co-funding digital

the project ‘Improving the quality and availability of medical

x-ray diagnostics for Poznan-Stare Miasto healthcare unit. The

services by purchasing the imaging equipment and medical

Opole ROP financed, among others, computed tomography equ-

products’.

ipment for an Independent Public Healthcare Unit in Glubczyce (contribution of PLN 1.29m or €0.3m).

ROP – EU support at the regional level Regional Operational Programmes (ROPs), established in 16 voivodeships, are fully financed by the European Regional

Funding at the national level The imaging diagnostic equipment can also be co-funded

Development Fund. Each ROP is administered by a given

at the national level, with the National Cancer Control Pro-

voivodeship’s local authorities supervised by the Coordination

gramme – established by an act of July 2005 – being the key

and Implementation of Regional Programmes Department in the

source of financing. Apart from cancer prevention and early

Ministry of Regional Development. The programme’s objectives

detection projects, improvement of cancer diagnostics’ quality

are being attained via identified priority axes determining basic

and treatment projects as well as educational projects, the

strategic solutions at the regional level.

programme also includes investment projects. These principally cover establishing a cancer radiotherapy system in Poland,

Principal beneficiaries of the financial contribution within

building PET centres and purchasing diagnostic equipment

RPOs considering healthcare include public healthcare units

for rapid detection of cancer. The last two tasks also cover the

operating within the public healthcare system excluding

purchase of imaging diagnostic equipment. In 2007-2009 over

institutions established by a minister, central government

20 institutions received a financial support for the purchase

administration authority, public university of medicine or a

of magnetic resonance imaging and other imaging diagnostic

public enterprise as well as non-public healthcare units opera-

equipment as well as for the purchase of PET-CT equipment,

ting within the public healthcare system. Different institutions

cyclotron as well as for the preparation of an infrastructure to

benefit from RPOs’ support in different voivodeships executing

install scanners.

RPOs. RPOs provide a contribution for modernisation and purchase of imaging diagnostic equipment as well as modernisation of

The article is based on the report “Imaging diagnostics market in

the current infrastructure and its adjustment to newly bought

Poland 2010. Development forecasts for 2010-2012” published by PMR

equipment. For example, the Wielkopolska Regional Operational

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36 | production

Production outsourcing scope Alessio Torresi

To define the activities and the related responsibilities, deemed as necessary for the correct management of the entire life cycle of equipment with CE brand and all the outsourcing-build product. It provides a guideline for the aforesaid activities, considering different casuistry to regulate Companies – supplier’s agreements.

Responsibilities

evaluation, minimum requirements of the supplier has to be

Company responsibilities:

verified.

• Company Direction has the responsibility to identify the processes oriented to an outsourcing management; • QA / QC has the responsibility, with the RA support if necessary, of

For this purpose, Company Direction has to provide exact input about the macro-structure of the desired outsourcing connection, while A&L, QA and RA, everyone for its competence area, have to verify, and

the identification and arrangement of internal activities to manage

afterwards, to define the most suitable configuration to assign to the

and control the outsourcing products, according to this procedure;

supplying connection.

• QA has the responsibility of manage formalized outsourcing processes inside the Technical Dossier related to the products / families of products involved (flowchart), including Company’s activities; • Is responsibility of the roles: ‫ ٶ‬Sales Manager or sales area or A&L, editing Commercial Contract;

Typology of outsourcing connection definition Outsourcing supplying connection can be summarized in macrogroups how listed in the table 1.

Based on corporate opportunity / needs, QA and RA establish operative details and regulation of working relationship, evaluating the

‫ ٶ‬QA and R&D, editing Technical Specifications;

certificatory state of the supplier (CE brand, certified Quality System),

‫ ٶ‬RA and QA the definition of Quality Agreement according to SOP

supplier’s company organization and experience regarding devices in

03.0.B.02; • A&L has the responsibility of archiving contractual documentation.

analysis.

The beginning of identified connection has to be anticipated by its regularization, through assignment of the mutual responsibilities

Supplier responsibilities: Suppliers have to manage the activities according to Commercial Contracts, Technical Specifications and Quality Agreement.

regarding economical aspect, operational and inherent informative flows.

To such purpose, commercial agreements are produced, (Direction, Commercial Area, A&L, et cetera…), Technical Specifications (QA and

Outsourcing strategy

R&D) and Quality Agreements (QA and RA), according to procedure

Outsourcing Processes Identification

03.B.02.

The decision of manage production processes of products, or phases of them, using external resources, is responsibility of the Company

Definition of goods handling route

Direction according to economical and organizational evaluations,

and type/phase of internal control

following opportunities, company strategy and growth of the period.

Outsourcing needs, in addition to economical and qualitative evaluations, regulatory evaluation; based on this regulatory

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Counting on productive organizations of supplier and customer and the required sterilization method, QA and A&L responsible, establish the most logical and economic route for the goods.

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37 Outsourcing Typology

Outsourcing Elements

Company product know-how

Company’s operational activities (*)

Supplier’s minimum requirements

Total

Design Client orders management [purchasing and raw materials quality control] Planning and supplier order Finished products quality control Final release

B. OEM

Planning Purchasing and raw material quality control Production Quality control Sterilization (if applicable)

Total

Client orders management Planning and supplier order Finished products quality control Final release

SGQ, able to release CE brand

C. OEM

Planning Purchasing and raw material quality control Production Quality control Sterilization (if applicable)

Limited or absent

Planning and supplier order Finished products quality control Final release

SGQ, able to release CE brand

A. Weaver

(Purchasing and raw materials quality control) Production Quality Control Sterilization (if applicable)

SGQ

Table 1.

Afterwards, QA responsible:

all the documentation to the supplier, during the starting phase of the

• Establish eventual internal controls and the relative phase where the

process.

check has to be made

Design, production (included purchase management and supplier

• Formalize entire process description in the product’s Technical Dossier furnished with flow charts if necessary.

control phases) and control activities are delegated to external resources.

If Company keeps independent Quality Control phases over finished

Outsourcing processes description and internal operative phases

product, the phases itself acquire acceptance control value, and can

Outsourcing type A – Weaver

condition, indifferently in weaver or in proper productive plant.

Productions belonging to this type of agreements are those that Company has intrinsic knowledge of the product itself and keep total and

be performed over the finished product both in sterile or non-sterile Every used approach, are managed with corporate procedures related to the area of interest; so are the phases and the types of control.

direct operativity regard design phase and modifications management of the devices.

Outsourcing type C – OEM

Only productions activities are delegated to external resources. The-

Productions belonging to this type of agreements are those that

se activities can incorporate raw materials buying and control, according

Company hasn’t or dispose of a limited intrinsic knowledge of the

to the agreement with the supplier. Company manage production and

product itself. In this case Company completely rely on the know-how of

control specifications.

experienced producers.

If Company keeps independent Quality Control phases over finished

Design, production (included purchase management and supplier

product, the phases itself acquire acceptance control value, and can

control phases) and control activities are delegated to external resour-

be performed over the finished product both in sterile or non-sterile

ces.

condition, indifferently in weaver or in proper productive plant.

Every used approach, are managed with corporate procedures related to the area of interest; so are the phases and the types of control.

Typically, the product specification, production and control activities (included purchase management and supplier control phases), are managed by the supplier, according to its Quality System. Company keeps a determinate control degree over the activities/changes of the

Outsourcing type B – OEM Productions belonging to this type of agreements are those that

supplier, based on the type of change and the commercial agreement.

If Company keeps independent Quality Control phases over finished

Company has intrinsic knowledge of the product itself. Generally, these

product, the phases itself acquire acceptance control value, and can

are production that were managed internally by Company, and, for this

be performed over the finished product both in sterile or non-sterile

type of outsourcing, Company transfer all the knowledge and eventually

condition, indifferently in weaver or in proper productive plant.

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38 | production

The role of statistics in risk analysis in the pharmaceutical industry Michał Iwaniec, Mirosław Popieluch StatSoft Polska

The management of risk in various pharmacy-related fields is a significant component of an effective quality management system. The ICH Q9 document highlights the importance of risk analysis, and also points out that the pharmaceutical industry does not make full use of all the benefits of such analysis. Risk itself is defined as a combination of the probability of the occurrence of damage and its severity.

Despite the best efforts it is not possible to completely eliminate the

data is used, it is hard to get by without making use of the tools of

risk associated with using pharmaceutical products. The risk associated

statistical data analysis.

with impaired quality of a medicine is just one of many elements, and

One of the more popular tools used in risk analysis is FMEA (Failure

attention should be paid to risk relating to other events which may occur

Mode and Effect Analysis), which refers to the analysis of types and

while a product functions on the market.

consequences of possible errors. This comes down to answering three

One of the rules of risk analysis is that it should be based on

questions:

scientific information, which means that risk analysis must not be

• What might happen?

founded on uncertain sources of knowledge. Often the source of

• What is the probability of an event occurring?

information which will be useful in risk analysis is data relating to

• What are its consequences?

product quality parameters, customer complaints, etc. There is usually a certain amount of random variation occurring in such data, and

We answer the first and third question based on knowledge of the

in order to obtain useful knowledge from it, appropriate methods of

problem, our expert knowledge, whereas if we have available data

statistical data analysis must be used. ICH Q9 recommends the use of

relating to the matter of interest to us, we can determine the probability

statistics to support the analysis of risk. In situations where historical

of its occurrence, using suitable statistical methods.

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39 The Q9 document proposes the use of various types of control charts and analysis of the ability of a process to describe a phenomenon of interest to us. In the example described below, a method will be presented for evaluating the probability of occurrence of certain events if we have not yet received information about such an event or if it has occurred very rarely, thus making proper evaluation of its probability impossible. The approach proposed below for evaluating the probability of an event from available data is based on scientific methods which, when properly used, minimize the error associated with human judgement.

Let us consider an example where we are interested in the filling of ampoules with a substance. So far, in standard production conditions, measurements have been made of the content of the substance for 100 ampoules. All of the values lie within the set limits (specifications).

Based on such information, can we conclude that the probability of obtaining an ampoule with too much or too little of the substance in the production process is equal to zero? Of course not, and in this case it is possible to evaluate the probability based not on intuition, but on scienti-

Figure 1. Control chart for 100 measured values of ampoule content, produced by STATISTICA

fic evidence. To evaluate the probability of occurrence of an adverse event, we use the control chart module in the STATISTICA program. On

and lower limit being exceeded. Often the appropriate distribution is

a control chart (Figure 1), 100 values of ampoule content are marked.

the normal distribution. This has the property that practically all values

We can see that none of the values lies outside either the upper or

ought to lie within three standard deviations of the mean value obtained

lower bound of the specification (USL;LSL). We can nonetheless see

from the measurements. Having a model of the shape of the distribution

with the naked eye that the values of the measurements are closer to

of measurement values, we can extend it to where no values have yet

the lower limit than to the upper one. It is therefore intuitive that the

been observed, namely beyond the limits of the specification. In other

lower specification limit is more likely to be breached than the upper

words, we can obtain the information which we would have obtained by

limit is. But what is the value of that probability? It turns out that we can

making a very large number of measurements, like one million.

model how the measurement values are distributed and, based on their theoretical distribution, evaluate the respective probabilities of the upper

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Figure 2 shows a histogram of actual measurements, with a theoretical normal distribution curve fitted. The “tails� of the

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40 | production The above example shows how to obtain knowledge about the dimensions of risk. Further assessment of the risk depends on the type of product, and only someone with knowledge about the dangers resulting from too small a quantity of medicine in an ampoule can answer the question of whether or not 654 PPM is an acceptable value.

If the estimated level of risk is acceptable, then the next question is how far we are able to monitor it, i.e. ensure that it does not change at some point in the future without our knowledge. Here we can again obtain help from statistics, and in particular from Shewhart control charts and the rational planning and performance of measurements. For example, the HACCP technique (Hazard Analysis and Critical Control Points) requires the constant monitoring of places where adverse events may occur. An example might be the monitoring of microbiological parameters.

If the risk level is unacceptable, it is necessary to make changes with the aim of reducing it. In the above example involving ampoules, Figure 2. Histogram for the quality of the ampoule production process, produced by STATISTICA

it would suffice to increase the average quantity of substance placed in the ampoules. In the case of actions taken to reduce risk, statistics

theoretical distribution curve never reach the value 0 – there always

can again bring assistance, making it possible to answer questions

exists a theoretical possibility of obtaining a value much greater or

such as whether the changes made have significantly affected the

much smaller than usual. The tails of the distribution therefore extend

process. In the simplest case one can, using the Basic Statistics and

beyond the specification limits: slightly more below the lower limit

Tables module in STATISTICA, perform a t-test comparing the average

and slightly less above the upper limit. The most difficult task now

values for measurements obtained before and after the implementation

remains, namely calculating the theoretical probability of an event

of the risk-reducing measures. For the more general case, namely

Figure 3. Probabilities calculated using the STATISTICA Probability Calculator

involving obtaining a measurement value outside the upper and lower

anywhere where the assumption of normality might not hold (such

specification limits. For this purpose we use the Probability Calculator

as for microbiological data), appropriate non-parametric tests can be

in STATISTICA. Figure 3 shows the method of calculating the two

used.

probabilities.

It turns out that the probability of the lower specification limit being

Although the ICH Q9 document enumerates many techniques assisting or connected with risk analysis, it points out that data analysis

exceeded is 0.000654, while for the upper limit the probability is almost

should be used wherever it is possible to do so. It is difficult in a single

0. Instead of a probability value, we can look at the risk of breaching the

article to highlight all aspects of the application of statistical methods in

specification in a different way, in terms of parts per million (PPM): how

risk analysis and in pharmacy, and so more information relating to the

many products in a million will be made outside the specification? This

use of statistics in various pharmacy-related problems can be found at

value is easily calculated as 654 PPM.

the portal www.statystyka-farmacja.pl

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ÂŽ

Central European Congress of Life Sciences

EUROBIOTECH 2010 Leading area: White Biotechnology

Krakow, Poland, 20-22 September, 2010 Main Organizers: University of Agriculture in Krakow

early registration on-line till 31th may 2010 on:

www.eurobiotech.krakow.pl

Jagiellonian University in Krakow

Targi w Krakowie Ltd

Venue: Jagiellonian University Department of Communication and Management (New CampusUJ) Prof. St. Ĺ ojasiewicza 4 Str. Partners:

Media Patronage:

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42 | production

Blazing a future-proof process path Mariusz Kłosiński Alfa Laval Polska Sp. z o.o.

Aptuit Laurus Pvt Limited, a joint venture between US-based Aptuit Inc. and India-based Laurus Labs Ltd., is a contract drug development company that two years ago began construction of a large-scale plant for the manufacturing of Active Pharmaceutical Ingredients (API), among other drug development activities, in India.

The parent companies is investing US $100 million over four

Limited to choose the best equipment for their processes, explains

years to ensure the new facility, located on over 34 acres of

Girish Kottapalli, General Manager.

land in Pharma City, 600 kilometers east of Hyderabad, India, has the most modern, state-of-the-art equipment, including more than hundred Alfa Laval spiral condensers, to provide costeffective solutions and exceptional service standards to its 600 pharma clients around the globe.

In the biopharm industry, there is intense competition to bring the latest products to market as quickly and cost-effectively as possible. Drug discovery is a very fast process, often rendering

Wanted: light, low-maintenance, low emission condensers When building the facility, the Aptuit engineers wanted to design a process that reduced solvent emissions into the atmosphere and offered maximum possible solvent recovery with minimum utility loads, thus reducing the environmental impact as well as costs.

The design criteria also called for equipment of proven techno-

today’s inventions obsolete in tomorrow’s market. Consequently, the

logy that was efficient, compact and weighed less than traditional

challenge is to optimize process optimization–the main reason why

shell and tube (S&T) condensers, the most common condenser

it is critical for a multi- purpose API plant like Aptuit Laurus Pvt

used in India. The engineers realized that utilizing standard S&T

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43

A small selection of the totally more than hundred spiral condensers installed at Aptuit Laurus Pvt Limited for condensation of solvents

condensers would involve the construction of a mezzanine floor for

Alfa Laval’s spiral condenser is an extremely compact circular heat exchanger with two concentric spiral channels, one for each fluid. The curved channels provide optimum heat transfer and flow conditions

These were not the only measureable benefits attributable to the

cleaning, maintenance and erection, which require a variety of tools

Alfa Laval technology. Utility consumption was slashed by 20 %

and tackles. Also, de-scaling these condensers is difficult and time

compared to S&T condensers due to the close temperature approach

consuming.

possible in spirals.

“Initially, we considered plate and frame condensers as they require less floor area and are easy to install,” says Kottapalli. “But the problem with these is the gaskets. There is no gasket material that can withstand the pressure from all the solvents.”

“When we compared Alfa Laval spiral condensers with other ava-

The human factor a big plus Working with Alfa Laval proved to be a positive experience for Aptuit. The sales people had a good knowledge of the product features and the technical staff was outstanding in its ability

ilable options we realized that these had a much better overall heat

to demonstrate the advantages of spiral condensers over more

transfer coefficient,” he adds. “Because the spiral condensers were

conventional technologies, according to Kottapalli.

compact, it would not only reduce 10 to 15 % in civil engineering costs but also save installation time.”

Moreover, the Alfa Laval staff was available when needed and provided practical approaches to problem solving, says Kottapalli.

However, because the facility is so new, there has been no expe-

Future proofing the facility Another important criteria in designing the facility was utilizing

rience or record in Alfa Laval’s maintenance or service provisioning.

Impressions of Alfa Laval equipment so far is that they are well

equipment that was flexible and capable of serving as a basis

designed products with high quality material, all backed up by

for future expansions as the factory increases its capacity. The

leading R&D capacity. “They understand the industry requirements

spiral technology drastically reduces the time needed for shifting

and their offers are in tune with these,” says Kottapalli.

and relocating condensers because they do not a require a heavy

“Our plant has set a trend for acquiring the latest technologies,”

structure and can be moved and placed easily. Alfa Laval’s compact

adds Kottapalli. “When our customers visit us and auditors call

equipment, proven technology and supportive and approachable

upon our facility, we highlight the importance of spiral condensers

team of service engineers were highly supportive of Aptuit’s vision,

in terms of their benefits. And most are impressed with them.

explains Kottapalli.

We are in fact promoting Alfa Laval condensers because of their

In the period the spiral condensers have been operating, the

efficiency and the good results we are getting.”

Aptuit engineers found the solvent recovery is more than 95 %, significantly higher than the traditional S&T condenser recovery of 60 to 70 %.

Alfa Laval Polska Sp. z o.o.

“The condensation of methylene chloride solvent in S&T is 70-80 liters per hour while Alfa Laval’s spiral condenser recovers 100 to 120 liters per hour,” adds Kottapalli.

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ul. J. Dąbrowskiego 113, 93-208 Łódź tel. +48 42 642 66 00 fax +48 42 641 71 78

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44 | production

Methods of granulation

Artur Jakubiak Pharma Consulting

Most solid pharmaceutical ingredients come in the form of fine, dusty, poorly flowing powders, and this causes major difficulties in controlling their quantities at the product forming stage.

Mixtures of fine particles with different dimensions, shapes and bulk densities have a tendency to undergo segregation when transported, while dust formation usually leads to losses and cross contamination.

To eliminate these problems, a granulation process is used. Granulates flow much more easily, and are resistant to suspension and bunching during pneumatic transportation. Their greater bulk density compared with powders makes them easier to store, transport and pack. Granulates absorb liquids much more easily than most powders, and hence also dissolve and disperse much faster. Through the choice of appropriate conditions of granulation, it is even possible to obtain properties which allow them to sink or float in a liquid, depending on requirements.

The choice of granulation method depends on what the granulate is to be used for (tablet forming, capsule filling, semi-finished product)

Figure 1. A compactor from Vector (USA)

This is the cheapest and easiest granulation process, typically used

and on which of its properties (flow, bulk density, granule shape,

to compress raw active pharmaceutical ingredients or mixtures with

homogeneity) is considered the priority. The method of granulation,

a high content of such ingredients, particularly products which are

and consequently the quality and form of the resulting granulate, also

sensitive to moisture. Drawbacks include the very limited possibility of

affects the release of active substance from the tablets, as well as other parameters.

In terms of how the process is carried out, granulation methods can be divided into dry and wet methods. Dry methods include compacting, while wet methods include granulation in fluidized beds and granulation in high shear mixers.

Dry granulation The process is carried out in devices known as compactors (Figure 1) using the mechanical force produced by two rollers rotating in opposite directions. As a result of the reduction in volume in the zone of maximum pressure, a ribbon of the product is formed constantly, and this is fed directly into a mill.

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Figure 2. Product after compacting

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45

controlling the size of granules, possible only at the stage of grinding of the compacted product. The typical form of a product obtained by this method is shown in Figure 2.

Wet granulation Granulation in high shear mixers The process is carried out in the devices illustrated in Figure 3.

Figure 3. High shear mixer with top drive, from Vector (USA)

Granulation is very quick, and the product obtained by this method displays greater sphericity than that obtained by compacting (Figure 4), although as in the previous case, particle size is controlled primarily at the grinding stage. Other drawbacks of this method include the lengthy contact of the compacted substance with moisture, the fact that the

Figure 4. Product of granulation in a high shear mixer

repeatability of the process is dependent on the temperature of the mixer bowl, and the need to apply a further three stages of processing (wet grinding, drying, and dry grinding).

The distributions of the sizes of the resulting granules and the content of active substance are shown in Figure 5. It can be observed that the highest proportions are accounted for by particles measuring 710–355 microns, 355–150 microns and 150–75 microns, which indicates a fairly wide distribution.

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46 | production

Granulation in a fluidized bed with top spray The main advantages of this method include the relative rapidity of granulation, the ability to control the size of granules, the narrow distribution (Figure 6), precise control of the process temperature, and the possibility of simultaneous drying. Grinding is required only in exceptional cases, and so the total time and number of stages in the process are smaller than in the case of granulation in a high shear mixer. Granulators are available Figure 5. Distribution of particle size in the case of granulation in a high shear mixer

in a wide range of working capacities, even up to 8400 l, and they are characteristically multifunctional, offering the ability to carry out three different processes: granulation, drying or coating of granules.

Figure 7. Rotor for a fluidized bed granulator, from Vector (USA)

Figure 6. Distribution of particle size for granulation in a fluidized bed with top spray

Figure 8. Product obtained in the Granulex process

Further improvement in the homogeneity of the granules can be attained by modifying the fluidized bed process to incorporate a rotor (Figure 7) enabling a spheronization process to be carried out (the Granulex process from Vector).

The resulting product is spherical (Figure 8) and highly homogeneous (Figure 9).

Figure 9. Distribution of particle size in the case of Vector’s Granulex process

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production | 47

Innovation instruments and techniques in pharmaceutical industry Dariusz Figiel Endress+Hauser Polska sp. z o.o.

Increasing highest quality continues to be a feature of the pharmaceutical industry. In the context of worldwide competition, this means that it is more important than ever to ensure optimum product quality while maximizing productivity. At the same time, operational safety must be guaranteed. Similarly, effective processes require a high degree of automation. Elaborate measurement and control systems in conjunction with automated process management concepts support plant operators in achieving these objectives.

Today, the use of process analytical measurement technology (PAT)

strategies, information and management tools. The term analytical is

compared together with perfect instruments

viewed broadly to include chemical, physical, microbiological, mathe-

is a significant component of measurement and control technology

matical and risk analysis conducted in an integral manner. In two main

in pharmaceutical plants as it also supplies data which are of utmost

steps of the full PAT innovation, the first one revolves around the process

importance to product quality and productivity.

itself and the second one focuses on the implementation of the relevant measurements and control system(s).

When PAT stimulates innovation Since the FDA introduced the PAT initiative back in 2002, several steps have been taken by both drug manufacturers and suppliers of

First step: A more robust process The process as a whole has to be understood because the whole

the critical process measuring instruments. Beyond these steps, new

process is involved. This responsibility lies with the drug manufacturer.

guidelines and standards have been created or updated, allowing the cul-

What is to be dealt with and how to focus on the biggest gaps has to be

tural evolution that is unavoidable when using such an approach. Quality

established before proceeding with the risk assessment. A selection of

risk management is integrated in the process for assessment, control

the most beneficial aspects and targets can then be selected after having

and communication, which means that the impact of the variability is

conducted this process overview. The critical set

understood by the pharmacist (impact on the patient) and the supplier.

of data to be collected and analyzed for the improvement of the process

The expected key innovation is the capability of suppliers to demonstrate

will then clearly appear. They have to be selected and mirrored regarding

that the reliability of the measurements induce the robustness of the

the targets. The selection of the data in question will generate project

process and consequently reinforce the quality of the drug, ultimately

priorities. Some of the priorities will appear after the risk analysis. Some

benefitting the patient.

others are directly linked to the implementation of the measurements

Process Analytical Technologies (PATs) have been defined by the

and control of the data, complexity of the relevant implementation,

FDA as systems for analysis and control of manufacturing processes

cost of the project as well as final benefit issues (process robustness)

based on timely measurements of critical parameters and performance

before any decision is made. This first step represents the most critical

attributes to assure acceptable end product quality at the completion of

one simply because it will have a direct impact on the optimization

the process. Process analytical technology involves optimal applications

approach. For doing this, the key is to create a competent team. Each

of process analytical chemistry tools, feedback process control

team member shall have in-depth knowledge of the most critical steps

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48 | production of the processing great detail. The selection of the team members within

the equipment, including the process measuring instruments and the

an organization according to this aspect, must also include expertise

control systems for manufacturing the drug. This impacts any equip-

on quality (any quality concern), science and attention to potential

ment that can potentially affect the quality of the drug which is produced

obstacles that may exist locally. As a team they will be able to identify the

(quality by design).

weaknesses of the process and identify where the process variability can be improved and existing sources of errors can be eliminated. A list of identified measurable and controllable parameters influencing the quality of the final product will be drawn up. Statistical process

Encouraging drug manufacturers and suppliers to closer collaboration Potential suppliers have to be in a position to demonstrate that

control (SPC) and monitoring of the data in question can eventually be

they have developed a Quality System which includes the GEP’s (Good

assessed and performed before any decision is taken. At this stage the

Engineering Practice). This is a precondition which is verified

question of how to implement the process improvement will be answered

by the manufacturers with supplier assessments and audits being

with: by selection of the adequate process measurements, control and

conducted. Documentation is one key (verification documentation). The

monitoring systems.

manufacturers expect to use the documentation created by the suppliers instead of producing it themselves. The management of the documenta-

Second step: process control and monitoring

tion has to also be done according to the guidelines. So the supplier has

After having understood the process it becomes urgent to eliminate

to objectively provide evidence that the specific requirements from the

any uncertainties which have been identified. True process optimization

drug manufacturers are fulfilled. Cost reductions are generated simply

being the challenge, the implementation of the measuring points

because by relying on a partner’s quality system and documentation, lots

and the controlling and monitoring strategies have to be conducted

of tests become redundant and need no longer be duplicated, thereby

according to the existing guidelines. The ASTM E 500 and GAMP5

saving on both costs and time. Project management tasks undertaken by

have to be used. They are the most universal guidelines and standards

the supplier (according to GAMP5) as well as allocation of budgets and

to-date. They include the risk based approach which verifies the patient

resources for integration of the equipment allow manufacturers to focus

protection while facilitating the engineering and quality principles. In

on their core competencies.

other words, the risk based but also the science based approaches will directly impact the design, the specification and also the verification of

Benefits Team working efficiency has shown that the myth becomes reality.

This is particularly crucial for complex process applications. The patient is the very first one to benefit from the greatly increased protection thanks to the more consistent quality of the drug. This is truly the

Fig. 1. pH electrodes for pharmaceutical industry

ultimate objective. The second “set of benefits” are enjoyed by the drug manufacturers: • Risk assessed in a positive fashion (expected skills and experiences put together) and errors eliminated as much as is humanly possible • Money is saved through peace of mind from the production side • Robustness of the process improved • Improved quality and better process variability • Confidence in working with the new PAT approach.

• Better knowledge of critical process parameters measurement by teams working with their partner.

The final group of benefits is generated by the contribution of the partner: • Projects conducted according to the rules: efficiency and execution • Cost reductions: duplications of tests avoided • Time reduction: competencies and knowledge of technologies, instruments and monitoring systems • Documentation delivered with the systems leads to simplifying the management of the project • High experience in qualification, verification and calibration leads to the best projects and fits the manufacturers’ expectations • Latest rules implemented for instruments and control or monitoring systems.

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production | 49 pH measurement technology in pharmaceutical processes However, it is the process analytical parameters in particular,

there are already sensors available for the measurement of pH, dissolved oxygen, conductivity and very soon also for turbidity measurement technology. In particular for pH measurement

including pH measurements, which require regular calibration or

technology, Endress+Hauser supplies all sensor types which

adjustment and regular maintenance more often than other controlled

ensure the safe operation of systems. The user can choose the

variables. Calibrations or adjustments must often be carried out several times a week in order to obtain a reproducible pH value when systems

most suitable sensor for a process from a range of sensors with liquid, gel or polymer electrolyte and with different diaphragm types, such as ceramic, teflon or open diaphragms. Enamel sensors from Pfaudler are now also available with Memosens technology. ISFET sensors complete the range. This means that the ideal sensor can be selected for each application.

The crucial factor in Memosens technology is that the digitalization of the analog measurement signal takes place directly in the sensor and that, in addition to the transmission of current measurement data, all quality-related data, such as temperature, calibration/adjustment values, location, total operating hours and operating times can be stored in extreme process conditions. This allows an optimal evaluation of measuring points to be carried out independently of location. In addition, the pH measurement is completely free of the interferences which present difficulties for classical, analog technology. The availability of sensor data at each location makes a change in maintenance strategy possible.

Fig. 1. Complete pH measuring loop

Conclusion What is the secret of successful implementation of PAT in the end ? Based on the teamwork abilities and capabilities of are in continuous operation.

The classical, analog, high-ohm systems in use are very susceptible to moisture, salt bridges, EMC

both parties, the drug manufacturer and the supplier, the partnership mentality induces several new keys: • Regarding the revenue, the improved quality, the better speed to

interference and potential overloads. This means that the sensor, cable

market and an improved flexibility which contributes to opening

and transmitter must be calibrated together. For service technicians, this

up new markets for the manufacturer

requires significant time and effort on site. Often the cable and sensor must be replaced to enable a fault diagnosis.

In addition, buffer solutions, cleaning solutions and water must

• The competence and knowledge on new process style, improved and innovative, including new technologies and tools • Reduced operating costs (fewer errors) while minimizing the risk.

be brought along when calibrating or adjusting a system. Spare

These three above-mentioned vectors represent some funda-

electrodes must be available in case an electrode needs to be

ments of a measurable innovation process.

replaced. In this case, a preliminary calibration is also required on site. It is also essential that the service technician registers at the plant, receives the necessary safety briefing and is in possession of

History Endress+Hauser was founded in 1953 by dr. Georg H. Endress

the necessary safety equipment. Difficulties arise if the fault must be

and Ludwig Hauser. The Endress family has been the sole owner

cleared at night time or at the weekend, as the necessary resources

of the company since 1975. In 1995, Klaus Endress took over the

must be scheduled. In all cases, the measured value is not available

management of the group from his father. For more than 50 years,

during repair.

the company has developed consistently from being a specialist in level measurement to a provider of complete solutions for industrial

Memosens – innovation technology Memosens sensor technology from Endress+Hauser is revolutionizing analytical measurement technology. Today,

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measuring technology and automation, while continually breaking into new markets. Endress+Hauser is now a leading worldwide company in process automation.

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50 | production

High sophisticated coating equipment for manufacturing of high sophisticated pharmaceuticals INNOJET

International competition and the development of high sophisticated drugs like Multiple Units Particle Systems (M.U.P.S.) with pellets implemented in Complex Pharmaceutical Dosage Forms with Modified Drug Delivery (e.g. implemented in tablets or capsules) forced the pharmaceutical industry to set-up new and challenging requirements for the suppliers of coating equipment.

And it’s not just about the profitable manufacturing of pellets made for M.U.P.S. in tablets or capsules which required a corresponding high-tech machinery but the global competition put the pressure on the pharmaceutical industry even to look for cost reductions and improvements on any other well established processes like granulation or the film coating of “common tablets”.

Above mentioned aims were the basic impulse for Dr. h.c.

Herbert Hüttlin to create various solutions around the established fluid-bed process and to accept the challenge of increasing demands of the pharmaceutical industry regarding process reproducibility, product quality and performance. And a major task too was to

Fig. 1.

enable a reliable scale-up. The result is a new and internationally patented product range of fluid bed devices for powder granulation, pellets composition and coating and for the film coating of tablets or capsules.

The three functional core components in a fluid-bed system which are directly affecting the process results by design and by the ability to set-up all of the major process parameters to make it reproducible, are: • The product container or fluid-bed bottom – It has to guarantee a homogeneous mixing and an effective contact of the product with the drying air. Humid particles have to be separated from each other to avoid agglomeration. The product has to be moved gently and without abrasions. The interaction of fluid bed – product movement and process air have to ensure a precise transmission of the parameter settings on to the product.

• The liquid spray system – It has to apply spray liquid to the product. Droplet size and spray quality have to be reproducible

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Fig. 2.

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51 • The INNOJET Rotary Spray Nozzle ROTOJET (2) (fig.2) is working under controlled and equal conditions and in line with the product flow. And additionally the design is made for a precise coating without the risk of clogging and it is good enough for most of applications where other systems are using up to 36 nozzles (which have to get cleaned as well by 36 and clogging is a topic too).

• The automatic and high efficient INNOJET Filter System SEPAJET (3) (fig.2) works in-process and continuously by using the process air which for instance results in

Fig. 3.

a 99% dust free granulate and it eliminates down times of the running procedures just for filter cleaning.

This three functional core components provide a precise and controlled procedure which can be handled from the operator by a touch screen panel. The complete process is running fully automated under digital control. The extraordinary results of performance and product quality are shown in the next two application examples for

Fig. 4.

both coating systems. rEklAMA

and the spray liquid has to reach the product surface without losses.

• The filtration system – It separates the product from the used process air. The filtration must be completely without influence to the process and the air stream has to be constant during the whole process time. In a granulation process the filter system has to provide a safe and reliable powder recycling to generate a nearly dust free granulated material.

The development of these three new core components was successfully finished by the establishment of the INNOJET VENTILUS Fluid-bed System for granulation and small particles coating up to dia. 2mm and the INNOJET AirCoater Fluid-bed System for film coating of particles from dia. 2mm up to length of 30mm like tablets or capsules. The product range is available from laboratory size to pilot scale and up to huge production capacities.

The major and patented features of the new INNOJET Technologies are: • The INNOJET Booster ORBITER (1) (fig.1) did replace the turbulent flow of a common fluid bed and its unsatisfactory performance by an exactly controlled and smooth Air Layer Gliding Process.

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52 | production 1. Manufacturing of Pellets for M.U.P.S. in tablets on INNOJET VENTILUS Equipment (source and copyright by ACINO PHARMA AG in CH-Basel www.acino-pharma.com) The use of pellets (multiple unit dosage forms) implemented in tablets provides to the patients many advantages compared to monolithic systems: The gastric transit time of pellets is largely independent of the filling degree and the motility of the stomach and they are able to pass the pylorus even in the fasted state.

Pellet-filled tablets with M.U.P.S. (fig.3) which reach the gastrointestinal tract (GIT) do disperse rapidly in the GIT

Fig. 5.

(fig.4) and thereby avoiding high local concentrations of the API which offen causes irritations or even ulcerations of the gastrointestinal system. Furthermore, multiple unit systems are of attractive appearance and its precise and simple handling enhances patient compliance.

ACINO has vast experience in development and manufacturing of multiple unit systems and M.U.P.S. implemented in tablets (like e.g. used for the API-s Oxycodone and Metoprolol).

The pellets are manufactured in a Suspension/Solution Layering Process (fig.5) on INNOJET VENTILUS Fluid-bed Equipments (fig.6).

For pellets manufacturing at ACINO there are in daily use

Fig. 6.

several production equipments INNOJET VENTILUS (800 litres and 200 litres) and two laboratory devices for R&D. The excellent quality of ready made pellets is shown in the graph of the Dissolution Test (fig.7) of pellets manufactured at ACINO. The pictures (Micro-CT) of the ready made tablets with M.U.P.S. (fig.8) give an insight into the structure of such a high sophisticated drug.

And INNOJET Technology works even in machines of other suppliers perfectly too after modification and the replacement

Fig. 7.

of old systems by INNOJET Functional Core Components.

Fig. 9.

Fig. 8.

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production | 53 The Dissolution Test of pellets manufactured on a conventional fluid-bed machine after modification with patented INNOJET Functional Core Components (fig.9) shows clearly the big improvements regarding quality and performance. The pharmaceutical company increased in this case their daily productivity by >20% compared to the previous operations.

2. Film Coating of Tablets in INNOJET AirCoater A 150 Fluid-Bed Coating System The basics of the INNOJET AirCoater System are the same as for the VENTILUS: It is the latest fluid-bed technology using Fig. 10.

the major functional core components which are unique and exclusively protected because of international patents hold by Dr. h.c. Herbert Hüttlin. There are the fluid-bed bottom and product container, but without the Filter System SEPAJET which is not required due to no need of a powder recycling process like in granulation.

The extraordinary performance of the AirCoater A 150 (fig.10) can be shown on this production example: • Round Tablets, 1000 mg, dia. 13mm • Film Coating OPADRY +3% • Batch size 150 kg, ready made coated and dried in 56min.

(81min. including WIP)

Fig. 11.

• 3-shift-capacity up to 3.600 kg per day • And the total process time mentioned does always include the charging and discharging process as well.

Easy access and simple handling (fig.11): The glass cover is easy to open. The operator can clean or maintain the coating device. As well the change of the two spray nozzles is made soon.

In comparison to a conventional film coating device there has to be considered a total process time of at least 2,5 hours to do a similar job e.g. on a drum coater. Additionally there are the further advantages or differences of the results like up to 50% less use of coating material to achieve a homogeneous film (fig.11) on the tablets as well as no abrasions and damages of the tablets, no overspray, no losses.

Fig. 12.

Conclusion The INNOJET VENTILUS and AirCoater Systems provide the latest state-of-the-art-technology for coating applications in the pharmaceutical industry acc. cGMP and to many other products too like powders, seeds, food additives, sweets, hot melt coatings, etc. (fig.13).

Up today there is hardly a sooner return on investment available with common systems and hardly a better performance to achieve for demanding coating applications with conventional fluid-bed equipments.

For further technical or sales information of InnoJet machinery please contact with Polish distributor, Arcon Poland, telephone 22/648-08-10 or sales@arcon.com.pl

Fig. 12.

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54 | logistics

On time delivering medicines

Consafe Logistics_Tagline

A scorching summer. Almost 40 Centigrade in the shade and air humidity much over 60 percent. And it has been going on for almost a month. Where?

In Poland. It is difficult to imagine such weather conditions at our latitude but it is happening now. During such periods, logistics and adequate transport of food or medicines become a problem.

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logistics | 55

A considerable part of materials, let alone food or medicines, change their characteristics in these conditions. As far as medicines are concerned, these

We need to remember that seconds, not minutes determine whether a treatment will be successful

conditions have an impact not only on their characteristics, but also on their effects.

Frankly speaking, medicines which are stored or transported in an inadequate manner, in inadequate temperatures or humidity, may pose mortal danger to people. „Nowadays, application of the HACCP procedures (Hazard Analysis and Critical Control Points — editor’s note) is not a requirement but a necessity,” says Marcin Michalski, Mobile Project Manager, Consafe Logistics, a supplier of shipment control and monitoring systems. “Although some statements sound banal, it is worth repeating them. Things like medicines must be transported in adequate conditions and there should be no exceptions to this rule,” the director of one of the biggest medicine wholesale companies accompanies him.

It is adequate temperature and humidity of the room that should be paid special attention to. “Our ControlTransport solution allows for constant monitoring of temperature inside vehicles that carry medicines and containers with medicines.

Each deviation from the standard is communicated with a special alert on the terminal or at the shipper’s”, says Michalski. The solution is integrated with temperature reading modules. A message is displayed immediately upon reading incorrect parameters.

Cars, e.g. cars of pharmaceutical wholesale businesses, for transporting medicines use special polystyrene foam containers marked with a bar code.

Information which and how many medicines are stored in a given container may be hidden in that code. You just have to scan the order to record the entire delivery in the system.

“Polystyrene foam containers are usually owned by the shipping company and are lent to pharmacies. ControlTransport is designed to control and monitor how many given containers are in a given pharmacy,” Michalski comments. And he adds that „the driver knows how many of them he has and how many he can take. Thanks to simple receipt features, the system quickly enters this information to the central system”.

Pharmacists can monitor their deliveries and estimate receipt time. “It is important, as far as information given to clients, especially elderly ones who come to fetch their medicines themselves, is concerned”, the owner of a pharmacy in the Warsaw’s Wilanów says.

Let us imagine a situation, where a hospital or a pharmacy places an urgent order for a medicine which they go short of or do not have at all. It sometimes happens that a medicine is needed immediately. When it turns out that the driver is unable to reach their destination on time, the doctors may think about a temporary alternative treatment. The shipping company may quickly set a new, faster route.

“We need to remember that seconds, not minutes determine whether a treatment will be successful,” a representative of a big British pharmaceutical company says. It is difficult to calculate delivery time in the city. Therefore, even the mere information that a medicine is being transported is invaluable.

ControlTransport is a sophisticated application designed not only for monitoring shipment status but for helping to find the shortest route or control transport conditions. And when a medicine reaches the pharmacy, it is enough to place a signature, which will be a Proof of Delivery, on the terminal. The shopping company has a proof that the medicines have been delivered to the right place. Wholesale businesses can also control their drivers. The systems integrate with Canbus, which makes it possible to control fuel consumption or traveled kilometers. “It is a very good solution for fleet managers,” a fleet manager in a big shipping company sums up.

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CEE region

Pharmaceutical logistics and its requirements Kuehne + Nagel explains what a 3PL provider needs Pharmaceutical market in Europe versus the United States Birgitt Smelty

Europe manufactures one third of all worldwide pharmaceuticals, making it the global no. 2 after the United States. In the year 2000, Europe’s output was just one third, so there is an enormous rising potential. Population is similar (United States: 297 million; Europe: 495 million), but the main reasons why the United States still have a superior industry are that the European pharmaceutical market is strongly regulated as well as fragmented.

Every European country has its own regulations, and production used to be highly dependent on the given transportation networks. Today, a trend is recognized that companies move away from that and globalize their logistics processes. So did the full-range logistics provider Kuehne + Nagel, offering state-of-the-art end-to-end logistics solutions. The wholesalers continue to develop logistics solutions that offer outsourcing possibilites to the producers. Europe has more privately owned pharmaceutical enterprises whereas the United States have many public companies on the pharmaceutical market. Thus, Europe and the United States have two different groups of companies acting on the pharmaceutical sector, meaning that global logisticians have to consider the various regulations on cargo space and the general transportation of pharmaceutics products.

Warehousing management is naturally easier to control and handle than the transportation of medical products by sea, air or road.

Pharmaceutics sector in Western Europe and the countries of Central and Eastern Europe (CEE) Worldwide forecasts announce increasing demands in the pharmaceuti-

Tobias Jerschke Managing Director of Kuehne + Nagel Poland

John Osullivan Senior Vice President, Strategic Customer Development Pharma/Healthcare

Hungary, Lithuania, Slovak Republic and Slovenia. The CEE pharmaceutical market has risen from $9.20 billion in 2006 to approx. $14.00 billion in 2010, still only 5 per cent of the world’s pharmaceutical output. In com-

cal sector meaning that this industry will continue to grow. But especially

parison, the pharmaceutical markets in the Western European countries,

European manufacturers are facing many challenges as well as opportuni-

including Austria, Belgium, France, Germany, Ireland, Italy, Netherlands,

ties. The pharmaceutical industry in Europe is changing and particularly

Portugal, Spain, Switzerland, and the UK accounted for $204.7 billion, and

3PL providers as Kuehne + Nagel have to be innovative and creative

forecasts predict a rise to $245.0 billion by 2012.

concerning their service and efficiency in logistics distribution. New ways in the pharmaceutical supply chain need to be developed and steadily implemented. European manufacturers of finished pharmaceuticals are located in Poland, Belgium, United Kingdom, Cyprus, Hungary, Austria,

Logistics in Europe need 3PL providers with panEuropean networks The European pharmaceutical industry’s growth obviously

Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France,

results in a higher amount of logistics operations. Europe’s target

Germany, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, Netherlands,

is to harmonize manufacturing in the different countries. Also, speciali-

Portugal, Romania, Slovenia, Spain, Sweden, Switzerland and Turkey.

zation plays a bigger role. In order to reach these targets, manufacturers

The CEE countries include Poland, Estonia, Latvia, the Czech Republic,

prefer 3PL providers with pan-European networks such as Kuehne + Nagel.

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57 The pharmaceutical & healthcare sector is complex and subject to global

cool-chain solutions for road, sea and air transportation across some of the

regulatory and quality compliance of the highest standards. Kuehne + Na-

major cities, coupled with strategically located contract logistics facilities

gel has been operating in this sector for many years and provides transport

such as Bratislava and Warsaw which underpin the commitment to the

services for life saving drugs, which include vaccines, prescription drugs,

customers. By supplying fully compliant and secure end-to-end solutions,

over-the-counter consumer goods, bio-tech samples for research and

including local distribution services in some challenging markets, Kuehne

development as well as clinical material, hospital supplies and medical

+ Nagel ensures highest quality standards. The industry is likely to grow in

equipment. Pharmaceutical & healthcare customers are looking for full

these countries, mainly driven by the demand for innovative drugs and the

transparency within their supply-chain. With cold-chain transports, even

increasing patient base. Ever growing research and development costs are

more information needs to be provided before the goods leave the dock.

driving big pharmaceutical and biotechnology companies to look for cost-

Customers need to know where the goods are in transit, whether they are

effective sourcing. Kuehne + Nagel’s main pharmaceutical manufacturing

secure, where the shipment is being held, whether it is clean and compliant

centres are located in Poland, the Czech Republic and Hungary. Those

and, in the event of a delay, what is the contingency plan for the shipment

countries actually dominate the CEE region in the pharmaceutical markets.

to be held at the correct temperature range. These factors alone represent

Particularly the increasing mortality rates in this region are the reason

true challenges for several logistics providers – but are routinely handled

why the cardiovascular sector is increasing. Cardiovascular therapies are

by Kuehne + Nagel.

of high importance, though a high level of generic medicines are offered in this region, reducing market growth. Poland, the Czech Republic and

Pharmaceutics 3PL companies should offer industry-specific solutions Pharmaceutical producers not only have high demands on the quality of logistics services, but also ask for industry-specific solutions which

Hungary have lower labour costs in comparison to other EU countries. In fact, the pharmaceutical sector is an important contributor to the European labor market – just about 600,000 employees are working in whole Europe, 115,000 of them in Research & Development (R&D).

need to be developed. A very close cooperation between the logistics provider and the pharmaceutical company is an essential key factor.

Most pharmaceuticals need temperature-controlled transportation and

CEE countries – hot spots for pharmaceutical R&D Production costs in the CEE countries are lower which is a significant

the according technology and processes. The temperature scale usually

reason for the growth in the pharmaceutical sector in this region. In com-

ranges from +2 to +8 degrees or from +15 to +25 degrees Celsius without

parison to other European countries as Germany, Austria or France, labour

any interruption. In regard to road freight solutions, Kuehne + Nagel

expenditure is very low. Thus, foreign investors more and more invest

provides special cooling trailers with thermo-controlled equipment and

into pharmaceutical research in the CEE countries. Many universities and

GPS tracking which can cover both temperature zones. Such devices are in

institutes for life sciences do exist in those countries. Recruiting patients

use, for example, for one of the world’s leading pharmaceutical companies

for clinical studies and trials is also easier than in Western European

in the distribution of their products from Austria to the Czech Republic,

countries, still the results will easily comply with all European regulations.

Poland, Hungary, Greece and Croatia. Envirotainers are in use for airfreight

Many local biotechnological enterprises already recognized this potential.

shipments. These containers, developed in the mid-nineties, provide

Around 1,000 studies per year are conducted within Poland, Hungary and

active temperature controlling for temperature-sensitive products such as

Czech Republic.

pharmaceuticals. Kuehne + Nagel has been the first Qualified Envirotainer Partner (QEP) worldwide. This accreditation certifies the service provider’s ability to meet the high obligations as defined in current good distribution

CEE countries get financial support The level of infant and general mortality rates and diseases in the CEE

practices guidance documents such as the Parenteral Drug Association

region is higher than in Western European countries as Germany or France

(PDA) Technical Report. The strategy of Kuehne + Nagel is to continue the

which has its reason in history, culture, higher poorness and differences in

further development of its pharmaceutical & healthcare logistics products

the general life style. There still is a lot of work to do. Unfortunately, many

across all its business units (Sea & Air and Road & Contract Logistics).

patients do not know how to efficiently pay for their healthcare. Public and

The company’s focus always is on the needs and challenges its customers face in their daily business. Accordingly, Kuehne + Nagel will continue to invest in new and innovative ideas for the transportation of cold-chain goods, while globally reinforcing its pharmaceutical & healthcare network of quality, compliance knowledge and expertise.

Eastern Europe – region with high interest and growing potential Especially Eastern Europe has been – and will continue to be – of strategic interest to Kuehne + Nagel. The pharmaceutical & healthcare industry in this region has developed very fast over the past several years and is expected to grow above average. Today Kuehne + Nagel offers

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58 | logistics private funding still need to be harmo-

respective requirements of the Polish Pharmaceutical License. As such,

nized. Also, CNS diseases and cancer

Kuehne + Nagel employed a certified and experienced pharma manager to

play a bigger role in the CEE region than

ensure compliance to its customers. The Polish Pharmaceutical License

in Western Europe which translates

was successfully gained in the first months of 2010 after passing the

into a strong growth of the according

required process.

therapy sectors. It is forecasted that CNS, cancer and cardiovascular alone will account for over 50 % of the

What logistics solutions in Poland must offer “Pharma customers expect highest quality from their logistics

pharmaceutical output market in the

providers. Through the investments kuehne + Nagel has made, we are one

near future.

of only few service providers in Poland who can provide those standards to our customers”, states Tobias Jerschke, Managing Direcor kuehne + Nagel

Generics more common than branded drugs Especially in Poland, Hungary and the Czech Republic, patients still are

Poland.

At present, Kuehne + Nagel operates logistics services for several large pharmaceutical customers. The main pharmaceutical & healthcare logistics

mainly asking for generic drugs instead of branded drugs, though there is

hub is located in Pruszkow, 15 kilometres outside of Warsaw. The shared

an increasing trend to branded drugs. But still, generic drugs are popular

facility offers one dedicated section of the warehouse to pharmaceutical

as they decrease healthcare costs for individuals. Many medicine products

& healthcare customers. It consists of a general storage area of over

are imported, leading to a slower industry growth in the CEE region.

4,000 square meters, a cold room for 100 pallet positions maintaining a temperature between +2 and +8 degrees Celsius, as well as inbound

Pharmaceutics logistics should be more important Especially temperature-controlled products should always be delivered

and outbound areas and a quarantine area. The storage section has been equipped with wall-insulation to maintain a temperature below 25 degrees

based on a dedicated logistics concept, because any time delays have

Celsius. The site has 24/7 security monitoring at the gate as well as

a bad influence on the safety and effect of medicaments. The resulting

security surveillance systems inside the premises during operating hours.

consequences can lead to reputational damages or liability cases. A

The hub is supported by highly qualified employees trained on serving

proven logistics concept also is essential for international clinical studies,

pharmaceutical & healthcare customers’ demands and expectations. A

otherwise the manufacturer or researcher will be losing millions of dollars.

quality measurement and control system ensures that all shipments are

When deciding for an unknown 3PL provider who is not able to execute

audited before shipping. Also, proactive feedback to pickers about errors

temperature-controlled transports in a trustful and reliable way, hidden

as well as kaizen workshops drive down process errors and continuously

operating costs can be very high. Spoilt products have to be replaced,

improve the quality of the operation. Kuehne + Nagel Poland pursues the

packed and shipped again, damaged ones to be destroyed.

company’s global strategy of growing in the pharmaceutical & healthcare logistics business by developing its existing and new customers and also

Pharmaceutical & healthcare solutions in Poland “Poland is the third largest pharmaceutical & healthcare market in Eastern Europe and continues to be an area of development for Kuehne + Nagel. With the sixth largest over-the-counter market in Europe, accounting for 2.5 billion dollars in 2009 alone, Poland is becoming increasingly

by serving additional Eastern European markets from its pharmaceutical hub in Pruszkow.

Pharma 3PL providers in future The global logistics market for pharmaceuticals is estimated at about

attractive for research and development. More and more pharmaceutical &

$30 billion. Particularly strong growth is observed in this segment in tem-

healthcare manufactures are looking to produce,

perature-sensitive pharmaceutical transports. Chilled transports between

store and distribute using the country as a strategic base”, says

+2 and +8 degrees Celsius or frozen transport drugs grow at an annual

John Osullivan, Kuehne + Nagel’s Senior Vice President Strategic

rate of about 15%. European expenditures in the area of pharmaceutics

Customer Development Pharma/Healthcare.

logistics probably will reach the mark of $2bn in the next two years. In the

In 2008, the pharmacy market in Poland reached $8.2 billion with

CEE region, forecasts are excellent for countries such as Poland, Hungary

a growth of 11.5% in comparison to 2007. In the years 2009 and 2010 the

and Czech Republic because the demand for innovative medicines will

compound annual growth rate was as high as 7.5%. In 2009,

rise in combination with the number of patients. R&D opportunities will

Kuehne + Nagel Poland made the strategic decision to increase invest-

attract foreign investors in that region. Challenges within the region are off

ments in the pharmaceutical & healthcare sector. The aim was to support

course the increasing requirements on 3PL providers and industry-specific

its customers in this industry with reliable and high quality logistics

logistics solutions for a clever pan-European and dedicated end-to-end

services. The first step was to receive the Polish logistics pharmaceutical

supply chain. Complex logistics solutions such as value-added services

license, which includes audits by the Polish Pharma Department, the

and a trustful cooling management are essential, increasing the outsour-

reviewing of all QSHE (quality, safety, health & environment) procedures

cing trend to 3PL providers such as Kuehne +Nagel with their stable global

and information system capabilities as well as trainings of its employees.

and pan-European network as well as strong financial power.

The company also invested in its human resources to comply with the

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logistisc | 59

Electronic commerce for the sake of pharmacy

Part II

Conditions of using barcodes Anna Kosmacz-Chodorowska Instytut Logistyki i Magazynowania – GS1 Polska

The previous edition initiated a series of publications aimed at providing our readers with IT solutions in the field of barcodes and electronic data interchange, currently being implemented within industry and business worldwide and in Poland, also in respect of pharmaceuticals.

We started with basic explanations and hints how to improve business processes in manufacturers and tradesmen: in warehouses and pharmacies as well as in hospitals. In order to make use of these opportunities, one has to become a member of the GS1 System (formerly: EAN.UCC).

This article will explain how to do it. In order to mark their products and logistics – shipping – units with barcodes, manufacturers / responsible entities and distributors must be active members of the system which administers these barcodes.

In the previous article we explained what automatic identification and

sector is concerned unfortunately only private solutions are applied.

data capture (ADC) and barcodes are; we presented their possibilities,

Functioning of EDI enhanced the meaning of the GS1 System mainly in

both from the point of view of internal processes of a company as

the field of coding products and companies (by means of the so-called

well as its business contacts with co-operators and providers of raw

location codes). These global identifiers, as already mentioned, were not

materials, packagings and other products including procurement

only used for automatic by means of barcodes but also in EDI messages.

materials; manufacturers of pharmaceuticals and medical devices called

During first implementations, separate EDI standards were developed

healthcare products, in consumer packagings – for retail, in collective

for each sector. Then, organisations implementing EDI, under the aegis

packagings – for wholesale and in logistics packagings – for transport

of the United Nations Organization, developed an international and

and distribution. We also mentioned how barcodes reached Europe and

intersector standard for EDI messages for industry, trade, transport

below we explain how they reached Poland and what their range is.

and administration, namely UN/EDIFACT. This was achieved through cooperation with standards organizations in the field of barcodes. The

Codes in Electronic Data Interchange Global GS1 Identifiers: GTINs for products, SSCCs for logistics units

GS1 organization (formerly: EAN International) developed a substandard of these messages – EANCOM – where all GS1 codes are used. EDI

(products on pallets or boxes of mixed content supplied to pharmacies)

Working Group associating representatives of industry, trade and

and GLNs – for identification of companies and physical locations,

services is currently acting in Poland. As a result of its efforts, most

were initially used only in automatic data capture systems via barcodes

commonly exchanged documents were agreed: invoice, order, despatch

and after that in electronic business messages. Since 1977 Electronic

advise, etc. They are uniform in Poland and compliant with global

Data Interchange consisting in paperless exchange of documents and

standards. Over a thousand of companies use these messages every

business information has become more and more common first in

day, especially in contacts between manufacturers and retailers. Because

America, then among many leading companies in Europe and Asia and

many pharmaceuticals, diet supplements and other healthcare products

for a few years also in Poland. However, as far as the pharmaceutical

are sold outside pharmacies, the quickest possible migration from

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60 | logistics

private – internal – to global solutions is even more purposeful. Relevant details will be the subject of one of the next articles. Right now we will focus on the current situation of barcodes in Poland.

• rules for marking entities and physical locations (e.g. companies, points of receipt and delivery) and • separate rules for marking particular sector products, e.g. registered pharmaceuticals, books and continuous publications and variable

Barcodes in Poland

measure groceries in retail packagings.

Despite the quick development of the use of barcodes worldwide, automatic identification and data capture had not functioned in

Moreover, GS1 Poland developed Polish system of marking variable

commerce in Poland for many years. At the same time there were no

measure products in retail packaging, e.g. products whose price is

publications on this topic. First in 1988 - on the initiative of the then

obtained by calculating the unit prices and weight (this system has

Ministry of Internal Market - efforts were made to include Poland into

been in forces since 1997). Such products hardly occur in our sector.

the international system of product marking and business information

In the pharmaceutical sector these products include raw and packaging

exchange - GS1 (then: EAN). The current Institute of Logistics and

materials e.g. foil as procurement products used in manufacturing

Warehousing in Poznań was entrusted to develop organisational, legal

processes in wholesale amounts.

and technical system aimed at implementing and disseminating GS1 barcodes (then: EAN) in Poland.

In 1990 EAN International admitted Poland to the GS1 System, registering Centre for Barcodes (currently: GS1 Poland) - seated in ILiM - as a member organization. By accessing the system, Poland

GS1 Poland developed rules for marking coupons and refund receipts as well as value vouchers which as promotion sales forms are more often used in trade – including our sector. All these rules apply to manufacturers and tradesmen of healthcare products.

For healthcare products, due to its sector requirements, international

obtained the right to allocate numbers to Polish products and companies

marking rules have been developed which for the reason of solutions

and mark them with barcodes in the GS1 System according to the rules

adopted in the past by regulating authorities like the Ministry of Health

agreed by GS1 and GS1 Poland. In the same year Polish Committee for

might:

Standardization published Polish standards related to GS1 barcodes and

• either be in the middle of migrating into global standards,

in 1992 another Polish standard - related to EDI - UN/EDIFACT - was

• or compliant with them from the very beginning,

published. In 1997 standards related to GS1 barcodes were replaced

• or – as in Poland – fully compliant with international standards

with European standards and currently – international ones, ISO – which

determining ways of identifying and coding all other products in unit,

obtained status of Polish standards.

collective and logistics packagings in the years 1990 – 1999; since

ILiM - GS1 Poland developed the following rules being in force in

December 1990 GTIN-13 numbers (often called EAN-13 which refers

Poland and compliant with GS1:

to the symbology in which they are presented on retail packagings of

• rules for marking trade items, including products in unit and

registered pharmaceuticals) have been allocated – only to registered

collective, retail and non-retail packagings, • rules for marking logistics / shipping units with transport labels,

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pharmaceuticals – by the agency of the Ministry of Health under the agreement between the Ministry and ILiM – GS1 Poland.

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logistisc | 61 Nevertheless, each manufacturer / responsible entity must be an

The founder and coordinator of this system is GS1, an organization ga-

active member of the GS1 System in Poland in order to mark registered

thering manufacturers, distributors and service providers from the whole

pharmaceuticals with GS1 barcodes (legal basis: Agreement between

world through a network of its representatives – member organizations.

the Ministry of Health and ILiM – GS1 Poland referring to unambiguous

In Poland this is the Institute of Logistics and Warehousing – GS1

identification of medical products, dated 28th August 2004 –

Poland, functioning for 20 years (although the system has been

the continuation of the agreement dated 6th December 12 1999).

functioning for over 30 years). These organizations are responsible for the system in particular countries which means that GS1 Poland is an

Who is responsible for product barcoding?

It is recommended that products should be marked by their

exclusive administrator of this system in Poland.

Any institution or legal entity might become a member of the

manufacturers or brand owners, e.g. by manufacturers being suppliers

GS1 System in Poland, regardless of the sector in which it operates.

of raw materials, semi-finished goods, etc., by manufacturers being

Participants of the system are divided into two groups:

suppliers of finished goods and by wholesalers only if they pack parti-

• companies marking their products, services, locations and assets

cular products themselves in their own trade packagings or when they code logistics units. Particular products are not marked by wholesaler because this would lead to a situation in which one product would have as many different numbers as there are wholesalers.

If any manufacturer or wholesaler, e.g. importer, has problems

with GS1 identification numbers and barcodes – these are most often manufacturers or distributors of goods (check earlier explanations); • trade companies (e.g. wholesalers and retailers), industry companies and services providers, etc. These are companies that implement or use the GS1 standards.

exacting product barcoding by a producer, he or she must solve this problem in a particular way. Here are some tips: • first of all, GS1 Poland will provide an importer with full information related to the GS1 Member Organization in this producer’s country if it’s not a member of the system and was unable to mark his or her

The prerequisite to join the GS1 System is to sign an agreement with ILiM - GS1 Poland and pay appropriate fees. Here are some details regarding this issue.

GS1 Poland entitles companies to mark unit items and collective and

products with barcodes. This information will enable him to complete

transport packagings with the GS1 barcodes, including GTINs obtained

all formalities in his or her country so that he or she is able to mark

on registration certificates from the Ministry of Health. In order to mark

further supplies to Poland in an appropriate way;

his or her products with the GS1 barcodes, each manufacturer and

• secondly, if a manufacturer or in importer has high inventory of raw

distributor must accomplish certain formalities by mail, in an electronic

materials and goods that have not been marked by suppliers yet, it is

way, in person or through a company providing such services. In order to

sufficient if these suppliers provide the wholesaler with GTINs of their

do so, necessary documents should be submitted:

products and then the wholesaler is able to mark the products with

• an application form which contains, apart from basic information

their numbers ordering self-adhesive labels with printed barcodes

about a company, a necessary number pool to mark all products

presenting those numbers;

(from 100 to 10 000 possibilities);

• finally, products may be marked by the retailer himself or herself. If the recipient – retailer – does not have all supplies marked according

• a copy of the company register and allocation of the company identification number called REGON.

to GS1 and does not have the manufacturer’s numbers, he or she may mark these products with the so-called internal numbers (13-digit numbers in EAN-13 begin with 20 or 04 and 8-digit numbers in EAN-

The fee consists of two elements: a one-off registration fee depending on the required number pool:

8 begin with 2 or 0). Use of any internal barcode symbols, including the ones mentioned above, limits their possible effects because they cannot be used for broader information exchange, e.g. with suppliers.

The so-called marking at source is most profitable because it makes it possible to use barcodes while dealing with the products, starting with their manufacturers. Below we present the terms of participation in the GS1 System for Polish companies which are manufacturers in the majority of cases and Polish representatives of foreign companies producing registered pharmaceuticals or middlemen.

Terms of participation in the GS1 System by Polish companies Polish manufacturers have been able to participate in the GS1 System only since 1990 and Polish companies representing foreign companies producing registered pharmaceuticals only since 1999.

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Registration fee Number pool do 100 do 1 000 do 10 000 do 100 000

Amount 250 zlotys 500 zlotys 1 000 zlotys 3 000 zlotys

and an annual fee depending on company’s net income in the previous year: Income

Annual fee

below 2 million zlotys between 2 million and 5 million zlotys between 5 million and 10 million zlotys between 10 million and 20 million zlotys between 20 million and 50 million zlotys between 50 million and 100 million zlotys od 100 mln do 500 mln zlotys powyżej 500 mln zlotys

100 zlotys 200 zlotys 500 zlotys 1 000 zlotys 1 800 zlotys 2 600 zlotys 3 400 zlotys 4 200 zlotys

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62 | logistics Depending on the date of joining the system, the annual fee is reduced by 25% each quarter. If a company joins the system in December, it is exempted from paying the fee for the last quarter and pays for the participation in the coming year.

It is important to mention that companies only using GTINs allocated

GTINs (it is not required to indicate check digits) preferably in EPS files that will be used by a graphic artist designing a packaging.

If our products do not have individual packagings or if we have goods or packagings without barcodes, it is possible to order self-adhesive labels with printed barcodes and numbers (it is not

by the Ministry of Health and not marking collective / logistics packa-

necessary to calculate check digits either). These labels are then

gings do not pay the one-off registration fee.

placed on packagings and goods not marked earlier.

Such an agreement is valid until the end of the first quarter of

Barcode prototypes and labels with barcodes are provided by

the consequent year. Companies willing to mark their products with

companies whose offer is available in the Internet at www.GS1pl.

GS1 barcodes should prolong the agreement every year, filling in the

org: Solution providers.

so-called Annual report (GS1 Poland form) - which includes report

Labels on shipping packagings with additional information,

data - and paying the annual fee until the end of March each year. In our

e.g. batch number and date, presented in a GS1-128 symbol,

opinion this might be an important reminder for all companies from our

are generated by means of specialized equipment and software.

sector that participate in the system.

A separate article will be devoted to this issue as well.

A company that joins the system obtains a number that identifies this company worldwide and entitles it to mark its products in various packaging forms. Most often unit items are marked with a 13-digit

Polish Database of Healthcare Products GS1 Poland initiates various activities and cooperates with

number, GTIN-13, presented in an EAN-13 barcode. Because this

many institutions and companies in order to develop new tool

number consists of:

improving e-commerce. In cooperation with IMS Poland – the

• a GS1 prefix which for Poland is 590;

owner of FBD BAZYL – the so-called Polish Database of Health-

• a company number or a number allocated by the Ministry of Health,

care Products was developed, enabling pharmaceutical companies

• an item reference determined by the company (manufacturer or the

being members of the GS1 System to:

Ministry of Health); • and a check digit (calculated according to a special GS1 algorithm, most often automatically, also in the process of generating the

• administer the catalogue of company’s products with GTINs (entry, correction completion of data, including GTINs which after being controlled update the catalogue and the whole base)

prototype of any barcode in EPS file which is necessary for a correct

• check the catalogue of all products (according to the database

print-out of the barcode symbol on a packaging or label), the compa-

of IMS Poland with already gathered information about pro-

ny number is of a variable length (4, 5, 6 or 7 digits), depending on

ducts) and to sort and select data.

how many numbers this company needs for its products.

Polish Database of Healthcare Products is an electronic Soon our readers will find out how to generate numbers and barcodes for:

catalogue, regularly updated and available in the Internet.

This is the first central database of healthcare products and

• small packagings

other products sold in pharmacies in Poland whose basic product

• variable measure items in packagings

identifier is GTIN (called also EAN). GTIN is useful for everyone.

• items in collective and transport packagings

It is encoded in GS1 barcodes on unit, collective and logistics

as well as how to obtain GS1 location numbers.

packagings guaranteeing faultlessness and automatic data entry into IT systems of companies – supply chain participants and

Product barcoding When a company obtains the above mentioned numbers, it is able

public administration.

Further practical information related to marking pharmaceutical

to mark its products with barcodes. In order to print barcode symbols

products generating their individual numbers will be available in

on packagings, it is sufficient to order barcode prototypes for particular

next articles. You’re welcome to get familiar with them.

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