View with images and charts Rangs Pharmaceuticals Limited Rangs Pharmaceuticals Ltd is committed to ensure better life through quality medicine. For this, we selected the Rangs pharmaceuticals ltd. to be trained which is already known as one of the growing pharmaceuticals in Bangladesh. We feel proud to take such a factory. INTRODUCTION RANGS Pharmaceuticals Ltd. is a leading edge pharmaceutical company and is a member of the RANGS Group, the largest private sector industrial conglomerate in Bangladesh. . The strategic strengths of RANGS Pharma are its strong brand recognition, highly skilled work force and diversified business mix. RANGS Pharma brands – Ostacid 500 Tablet (Calcium), Diversa Gold Tablet (Multivitamin’s and Multiminerals), E-Gold Capsule (Vitamin-E), Prevencid Capsule (Omeprazole), Antipro Suspension (Metronidazole), Oryx (1g IV Inj) (Ceftriaxone) are among the most recognized brands in the Bangladesh Pharmaceutical Industry. RANGS Pharma manufactures a range of dosage forms including tablets, capsules, dry syrup, Suspension, Syrup, powder, Injectable Product etc. in several world-class manufacturing plants, ensuring high quality standards complying with the World Health Organization (WHO) approved current Good Manufacturing Practices (cGMP). WAREHOUSE Warehouse is an important part of any pharmaceuticals company. RANGS pharmaceuticals Ltd. Is one of the well known pharmaceuticals industry in Bangladesh and has many products in market. So, its warehouse also has many responsibilities. Warehouse is the place where materials are preserved and distributed. •
Areas of Ware-house
1. Quarantine area:-After receiving raw and packaging materials are kept here for QA approval. 2. Released area:-After getting approval raw and packaging materials are kept here with great safety. Released area is generally the central area of ware-house. 3. In process area:- According to store requisition(SR)dispensed materials for manufacturing are kept here. 4. Rejected area:-Raw material, packaging material and finished products which are unable to get approval from QA are retained here with great safety .Usually this area is located at the corner of the warehouse. 5. Finished product area:-Generally finished products are started here for delivery to I 2 I service. 6. Special area:-It includes cool room, for heat sensitive and flammable materials. Identification of products and raw or packaging material in Ware-house. •
Raw materials and finished products are easily identified here with the help of an index which includes different code for different area also.
•
Packaging materials in warehouse are kept or placed following Alphabetical order.
Activities of ware-house:Activities of ware-house can be divided into 2 parts. 1. Routine Activities 2. Periodic Activities. FLOW CHART of routine ware-house activities (Related to raw and packaging material) Arrival of materials Invoice checking
Unloading Cleaning Physical inspection and receipt/Discrepancy report Quarantine storage Log book entry / MRR for received items Q.A sampling QA release / reject MRR / Failed MRR
Disposition Of released / /rejected materials
Disposition/Distribution Computer entry of requisition / monthly inventory report. Note: Log book entry of product includes date, “R” No. (for raw materials), “p” (for packaging materials) manufacture / supplier, purchase order No., total weight received, number and size of containers name, invoice no. etc. Dispensing It means the materials are supplied to the production areas by weighing according to the proper document and release it from the RM store. FIFO The term FIFO stands for First In First Out • Handling of finished goods by Ware-house:(It is also a routine practice of warehouse) Finished goods transfer note from solid, liquid and antibiotics QA released tag Verification by warehouse VAT payment VAT challan (Musak-11) Entry in purchase register (Musak-17) Entry in sales register (Musak-16) Entry in VAT current account register (Musak-18) Balancing VAT payment register Delivery advice for distribution Prepare dispar dispatch VAT challan(musak-11) Delivery to Distribution godown Current account reconciliation
Note(4
copise)
prepare
custom
Finished goods reconciliation Role of warehouse in New product Launching Production
Applycosting to the customs With received from accounts Approval from drug administration And bill of entry
Received of an applied copy
QA test & released tag
Product release Dispensing areas of Warehouse:One dispensing officer always responsible for dispensing the raw materials to the production and packing materials to the packing areas. Following things must be checked by the dispensing officer. 1) Check that only approved (green tag) materials are brought to the dispensing area. 2) Check that dispensing area is completely free from others materials. 3) Check that cleaning is done with IPA and savlon solution. 4) Check that correct quantity and approved quality of materials are being dispensed as per requisition. 5) Check that materials come first are being dispensed first, to follow FIFO (First In First Out). Documentation in Dispensing:Documentation includes, a) Serial number
b) c) d) e) f) g) h) i)
Product name and code Product batch number Requisition entry Cleaning Material exit Remarks Tags Signature of authorized person etc.
Inventory Functions of Warehouse:Inventory
After reading MRR to QA department materials will be kept pending list in computer
After getting released from QA department product will be at Normal inventory
Stock will be deducted from stock against S.R.(Store requisition) after dispensing. PRODUCTION Production area of RANGS pharmaceuticals are divided in to some major part. Production areas are – Tableting area Coating area Blistering area Capsule filling area s Packaging printing area PRODUCTON ACTIVITY
Warehouse – 1
Dispensing
Processing
Granulation Compression Tablet coating Liquid bulk Manufacturing Filling Packing
Finished product
Warehouse – 2
TABLETING AREA Tablet manufacturing and design is the most important, challenging and also critical process. To maintain its correct amount of drug(s) in the dosage form, extra care and alertness is essential in the tablet manufacturing process. Tablet constitutes a major class of dosage form. RANGS Pharmaceuticals produces commercial batch by validating the processes. . They follow o cGMP o SOP and o BMR during tablet manufacturing. SOME BASIC REQUIREMENTS FOR SUCCESSFUL TABLET MANUFACTURING This pharmaceutical follows some basic requirements for quality tablet production. Such as:
Design During our training period in tablet section we observed that solid manufacturing section is well designed. They have•
Separate rooms for different operations.
•
There are two separate entrances for personnel and material respectively.
•
Air lock doors. The operators don’t open the two doors simultaneously.
•
Rooms are partitioned by transparent glass, which facilitates visual inspection from adjacent and far rooms.
•
Floor and walls have no sharp edges which prevents dust deposition.
•
Floor is painted by epoxy paint.
Rooms include within the tablet section are: •
Hand washing, shoe cover & gown wearing room.
•
Office room for production officers.
•
Solution preparation room.
•
Coating room
•
Dispensing room.
•
Store
•
Granulation and blending room
•
Equipment store (mainly die and punch are stored here)
•
Compression room
•
Capsule filling room
Facility For cGMP RANGS Pharmaceuticals have some essential facilities in solid manufacturing area. They have• • • • • • • • • • •
Adequate space for separate operation Adequate electricity supply HVAC system PW (Process Water) supply HPS (High Pressure Steam) supply ICA (Instrumental Compressed Air) Supply Vacuum line Pressure differential gauze. Positive air pressure. Telephone Generator
Equipment
Advanced machine are available in tablet manufacturing unit. For using equipments following points are maintained: •
Safety card: provides safety instructions to machine operators.
•
Labeling: describes state of operation. As for example: MACHINE LABEL: TO BE CLEANED, CLEANED, UNDER TEST, UNDER PROCESSING etc.
•
Machine logbook.
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Proper cleaning of the machine.
•
List of authorized persons.
Personnel All the process is validated in RANGS. In solid manufacturing unit, highly trained, experienced and skilled personnel are involved in tablet manufacturing i.e. Granulation, compression, and coating RANGS is rich in skilled persons in tablet section. They are serving for the company for a long period. For the health and safety of the operators RANGS provides: •
Gowning
•
Mask
•
Shoes
•
Ear protector
•
Shoe cover
•
Glovess
Different Solid Manufacturing Unit The different solid manufacturing units are:
Dispensing unit Granulation unit o Dry granulation o Wet granulation Compression unit Coating unit
Dispensing unit The manufacturing unit sends a demand paper according to their need, to the warehouse. Central Dispensing Unit weighs the required amount of active ingredient & excipients and then sends it to the manufacturing unit. Manufacturing unit received and rechecked it. Raw materials must be approved from QC department before dispensing.
Granulation unit
There are two types of granulation: 1. 2.
Dry granulation Wet granulation
STEPS OF GRANULATION PROCESS From dispensing unit
Active ingredient & Excipients
Milling (size reduction & sieving)
Drying
Further milling
Granulation unit
Mixing of Active ingredient & Excipients
Blending
Compression unit After proper blending granules are stored in a container and then it is delivered to the compression unit. Before compression some parameters are checked: • • • • • • • • •
Proper cleaning of machine. Proper arrangement of die and punch. Removal of all the material relevant to previous product HVAC system. Dust collecting system Humidity Temperature Pressure differential Granules are poured into hopper
Coating unit
Coating is one of the important steps after compression. Reasons for coatingo
Stability
Taste masking Elegance etc.
o o
TYPES COATING DONE BY RANGS Sugar coating Film coating: Aqueous coating Organic solvent coating Enteric coating.
• •
•
TABLET TEST After compression and coating tablets are delivered to QC for some test. The tests are: o o o o o o o
Appearance Weight variation Friability Disintegration time test Dissolution test Thickness Hardness
Capsule It is a solid or liquid dosage form which is manufactured by enclosing into capsule shell. Types of capsule shell: 1. Hard gelatin capsule shell and 2. Soft gelatin capsule shell. RANGS pharma manufacture capsules by using hard gelatin capsule shell and also liquid capsules. Instrument used for manufacturing capsules: 1. Auto capsule filling and sealing machine: It consists ofo Capsule shell hopper o Rectifier o Granules or pellet hopper. o Filling station o Sealing station o Rejecting station. o Discharge station. 2. Capsule sorter 3. Blending apparatus Manufacturing process: Granulation
Blending
pellet
Filling Sealing Monitoring or sorting Blistering Packaging Precaution: Incase of capsule manufacturing the following precaution should maintain for the stability of capsule shell: 1. Temperature must below 25 ยบC. 2. Moisture must below 50%. In this unit powder and pellets are just filled into shell. LISTS OF INSTRUMENTS USED IN PRODUCTION 1. Rapid Mixer granulator (RMG-400) Type: CPMRMG 400 Capacity- 250 KG Origin: INDIA 2. Solace Aero Dryer Capacity- 120 KG Origin: INDIA 3. Blending Machine V- Blender 4. Crashing Machine 5. Double Rotary Tablet Compression Machine Type: CPM D3 Origin: INDIA 6. Semi Auto Capsule Sealing Machine Pam Pharmaceutical And Allied Machinery Company Pvt. Ltd. Origin: INDIA
7. Automatic liquid Filling M/C LF 40 Pam Pharmaceutical And Allied Machinery Company Pvt. Ltd. Origin: INDIA 8.
Coating Machine Name: N.R. Coater Origin: Thailand Capacity: 60 kg
9. Coating Machine Name: N.R. Coater Origin: Thailand Capacity: 50 kg 10. Pest preparation Vessel Capacity: 80 kg 11.
Blister-1 HOONGA Model: Ministar – N5 Capacity: 60 RPM Power Supply: 380 Volt. Weight: 2600 kg Origin: Korea
12.
Blister-2 HOONGA Model: Ministar – N5 Capacity: 60 RPM Power Supply: 380 Volt. Weight: 2600 kg Origin: Korea
13.
Capsule and Tablet Bottle Filling Maximum: 90 RPM
14.
Ampoule filling washing Machine
PACKAGING AREA Solid drugs (Tablets, Capsules) are packed in this section. Two types of packing materials are used here. 1. Primary Packing Materials
These materials actually come into the contact of products; such as aluminium foil, PVC film, PVDC film etc. 2. Secondary Packing Materials These materials do not come into the contact of the product rather they provide extra protection and facilities for transport and use. These materials include• • • • •
Printed cartoon Fiberboard outer Filament partition Liner Cellulose tape
Packing Machines There are two types of machines for packing products. Blister packing machine and Strip packing machine. There are a few strip-packing machines among which one is used for striping. The Blister packing machines are kept inside separated rooms to maintain healthy environment as well as safety. Each of the rooms is facilitated with individual Air Conditioning System. MACHINE USED IN BLISTERING PURPOSE There are some blistering machines used. Machines are gives following o o
Blister Packing Machine Blister Packing Machine
PROCESS OF BLISTERING Blister packing is the most common practice in RANGS. Most of the products are packed in this method. Usually PVC film and Aluminium foil are used for this purpose. And Al-Al also is used for some heat and light sensitive products. The steps involved in Blistering are: • • • • • • •
Rolling of PVC Pocket formation by heat and vacuum pressure Transfer of tablets or capsules in the pockets Sealing of the pocket by Aluminium foil using heat Printing over the foil if required Perforation of the strips Cutting of the strips.
The strips are checked for any kind of leakage every half hourly. The instrument used isThis machine is operated at 380-400 mm Hg pressure for two and half minutes. After completion of blistering, the finished strips are then sent to the packing lines. There the following steps are done-
• • • • • • • •
Feeding Laying Visual checking Cartoon making Inserting Flap closing and Tapping Outer making and filling Outer closing.
Finally the finished packets are sent to warehouse after Quality Assurance approval. PARENTERAL AREA INSTRUMENTS USED IN PARENTERAL PRODUCTION 1.
Most – heart sterilization • •
Temperature control: 121° C for 15min Sterile materials – a) b) c) d)
2.
Rubber stroper Flip of seal Filling ampoule Contact parts
Dry Heat sterilizer: • •
Temperature control; 260°C/200°C Sterile materials – a) Ampoule – 200°C for 1 hr. b) Vial – 250° C for 30 min.
3.
Burring washing machine: •
4.
Rubber stroper.
Distillation chamber: • •
Temp: 300°C Stilmass – Italy.
5.
Laminaire.
6.
Manufacturing vessel.
7.
Holding vessel.
8.
Lyophilized Microscope
9. Lyophilizers Sterilization process: 1. Vials are usually sterilized or depyrogenation by using dry heat sterilizer at 250 ยบC for 30 mins. 2. Garments, gloves, machine parts or equipments are sterilized by 121 ยบC for 15 mins. AREAS OF STERILE DEPARTMENT Class A Class B Class C Class D
Area under laminar airflow
Class E1
Aseptic filling room Aseptic manufacturing & terminal filling Terminal product manufacturing 1. Bottle washing 2. Dispensing 3. Other area of class 10,000 Material entry, inspection & sterilization
Class E2
Packaging
Visiting site: Ampoules (Injection) Ampoules: Ampoules are special type of container used for WFI or RANGS preparations. Ampoule department of Beacon Pharma: RANGS pharma has a well established and strong ampoule filling and sealing department in non-cepha building. The most highlighted point is that it has the largest and more efficient filling and sealing machine which is completely automatic. Instruments used for injections (ampoule manufacturing): 1. Auto ampoule filling and sealing machine. 2. ampoule washing machine 3. Autoclave 4. Dry heat sterilizer 5. Charge vat 6. Cartilage filter unit Mechanism of ampoule washing: Ampoules are placed manually on tray Passed through change box to ampoule washing room
Ampoules tray are placed in washing machine where A flash of DM + WFI flows from upper and lower part Of the machine After certain period it is removed and the ampoules are replaced from that tray to another tray
Performed dry heat sterilization for Depyrogenation at 260 ÂşC for 2.5 hrs.
Allowed to cool and remove it for filling And sealing in aseptic area
Mechanism of filling and sealing: Ingredients are charged in charge vat in normal area Allowed to pass through cartilage filter ( 0.2 Âľm) Unit and collected into storage vessel in aseptic area
Then ampoules are filled from these Vessels by the following ways Injectable solutions or WFI are collected by The pipe of auto filling and sealing machine Ampoules are placed on feed pan Ampoules move towards nozzle by the help of conveyer system At first ampoules are flashed by nitrous oxide gas
filling
Pre heat by flame Sealing Terminal sterilization
Packaging Important notes: o Pressurized system is used for charging, passing through cartilage filter unit, filling etc. o Terminal sterilization is not performed for heat sensitive substances. Ex- vitamin preparations. o Filling and sealing is performed under laminar air flow unit under aseptic condition. Visiting site: Injection (vials) Injection (vials): Vials are sterile glass containers whose volume up to 15 ml. This volume also may be up to 30 ml. usually vials are widely used for injectable preparations. Instruments used for injectable vials: 1. 2. 3. 4. 5. 6.
Washing machine. Dry heat sterilizer. Autoclave. Auto filling and sealing machine. Auto labeling machine. Auto vial blistering machine.
Process of washing: Place vials on inspection platform Charge inverter nylon arm Wash with the flash of Demineralized water (DM) water
And Water for injection (WFI) from upper and lower parts Air dry Wash with DM water Air dry Wash with WFI Final air dry Then discharge inverter nylon arm Placed on tray for depyrogenation Manufacturing process: Receive ingredients Deboxing Passed through change box under laminar air flow Filling and sealing in aseptic condition Finally blistering and packaging Types of packaging materials: 1. Primary packaging materials: it includes o Glass vials (7.5 ml or 15 ml) o Rubber stopper o Flip off seal 2. Secondary packaging materials: It includeso Comb pack o Leaflet
o o o o o
Disposable syringe Baby needle Butterfly syringe Inner cartoon Master cartoon
MICROBIOLOGICAL LABORATORY The department of Microbiology performs the role of immense importance to follow the cGMP and to formulate as well as to implement the SOPs. RESPONSIBILITIES The overall activity profile of the microbiological section of QC department of RANGS can be presented briefly in the following way-----Microbial count
Pyrogen test (LAL test) sterility test
Environmental study
Preservative efficacy test
Water, Raw materials. Bulk samples, finished products (sterile) packaging containers Water, injectables.raw materials, other sterile products All manufacturing & filling areas including aseptic filling room. Finished pack samples, preservatives
Validation
Steam & dry heat sterilization, oven cleaned equipment
Pyrogen hygiene test
All production area operation
Bioassay
Antibiotic, raw materials, comparative study of other antibiotics
Penicillin cross contamination study INSTRUMENTS US
Penicillin in environment & non-penicillin production area
INST INSTRUMENTS USED IN MICROBIOLOGICAL ASSAY RUMENTS USED IN MICROBIOLOGICAL ASSA • Particle counter
• • • • • • • • • • • • • • • •
Air sampler Incubator (Hot / Cool) Vortex mixture Centrifuge machine Water bath Freeze to preserve bacteria Air born particle counter Colony counter Microscope Laminar flow machine Hot oven Dust collector Autoclave Balance LAL testing kit High precision bath
The 3 tests are done here. 1. Receiving inspection. 2. In process inspection. 3. Final inspections. INSTRUMENTS USED IN THIS LAB 1. Laminar air flow –
Total bacterial count. Fungal count. Pathogen test of non-parenteral products.
2. Particle analyzer. 3. Batch sampler. 4. Cooled incubator Temp. 22° C 5. Incubator Temp for 37° C for bacterial culture. 6. Freez for microbial culture. 7. Dry heat sterilizer. 8. Autoclave. 9. Laminere air flow for sterility testing.
MEDIAS
Broth media : o TSB. o Macconkey broth media. o Lactose broth. Agar media: o TSA – Bacteria test. o MEA – Fungus test. o MCA – Pathogen test. Microbiological testing procedure for different products are performed as follows –
For Parenteral products: o Sterility test. o Pyrogen test. For Raw Material : For specified raw materials – By pour plate method. Environmental study: o RCS air sampler. o Settle plate. QUALITY ASSURANCE DEPARTMENT Quality Assurance department is responsible for assuring that the quality policies adopted by a company are followed and in most organizations it serves as the contact with regulatory agencies and are the final authority for product acceptance or rejection. It also helps to prepare the standard operating procedures (SOP) related to the control of quality Quality assurance means the sum total of the organized arrangements made with the object of ensuring that products will be at the quality required by their intended use. It is thus GMP plus factors outside the scope of ISO guidelines. The function of QA starts from raw materials and continues up to released products. The function of QA in a pharmaceutical is given below. BEFORE PURCHASING
Environment of the suppliers are also sensitive for purchasing of raw materials. QA checks the environment before purchasing the active pharmaceutical ingredients (API). IN WARE HOUSE
Identification of raw materials (RM / PM) Check the quality by QC Orientation of raw materials. Orientation of packaging materials. QA inspection and report submission to the head of QC. Sampling for, o Lab sample. o Microbiological sample. o Retention sample.
Released and rejection works of raw materials and packaging materials.
IN PRODUCTION AREA ■ Before starting of manufacturing the cleaning operation or change over of machineries is cheeked by the Q.A. ■ Line clearance. ■ In process QC. ■ For solid production the following tests are done – o o o o o o
Weight variation Hardness Thickness Diameter Friability Disintegration Test
■ For L.C.O.o Weight o Volume checking. IN ASEPTIC AREA Air particle monitoring, microbiological tests (swap test), water test and treatment are done by microbiological department under the supervision of QA. IN PACKAGING AREA ■ QA officer give the line clearance for starting of packaging operation after assuring the following points: o Absence of product of previous order.
o Absence of packaging material belonging to the previous order. o Cleanliness. ■ ■ ■ ■ ■ ■
QA officer check the batch no. Mfg. & Expiry date. Random checking of blister & strip. Random wt. checking for cream and ointment. Random volume checking for liquid during filling. Check of inner and shipping cartoon. Evaluation and repacking of accidental damaged goods.
QULALITY CONTROL Now a days the manufacturing of Pharmaceuticals is quite complex & there also arise some responsibilities; for example ethical, legal and economic responsibilities. These responsibilities are immensely important for the production, control & marketing of quality products. A systematic checking from the raw materials in process, Packaging materials, labeling & finished products can ensure quality products. This is the Prime concern of the industrial Quality & Compliance Department. The Concept of total Quality refers to the process of striving to produce a perfect product by a series of measures requiring an organized effort by the entire company to prevent or eliminate errors at every stage in the production. During our training part in QC, we observed that RANGS performs almost everything that ensures quality of medicine Quality control (QC) is one of the major and global concerns for the entire sector in any industry or company. It is the combination of skills personnel, valided method, part of GMP which is concerned with sampling, specification and testing to ensure that the necessary and relevant taste are carried out and that materials are not released for used until the quality has been judged to be satisfactory. This part is responsible for chemicals test, identification, and separation of any sample. Quality control department involved with the raw materials testing, stability testing, and calibration of all apparatus, microbiological testing, analytical development and validation, documentation and routine analysis, bulk sample testing and packaging materials. OPERATION PERFORMED BY QC LABORATORY ARE DESCRIBED AS FOLLOWS: TESTS FOR RAW MATERIALS • • •
Physical properties (appearance, solubility etc) Assay Other specified tests like identification (chemical and photometric), determination of purity, optical rotation, water content determination.
IN PROCESS QC • • •
Quantitative assay Disintegration test pH
• • • • •
Viscosity test Weight / ml for liquids Microbiological assay Weight variation tests Environmental monitoring
FOR FINISHED PRODUCTS • • • • • •
Description Assay Specified identification test Leak test Disintegration test for coated tablets Stability test
TESTS FOR PACKAGING MATERIALS •
•
•
•
•
Packets
Cap
Bottle
Aluminum Foil
Label
• • • • •
Printing error test, Length, width of secondary packing materials, Lock bottom test, Defection of gluing, Wide color variation.
• • • • •
Color, Printing, Weight, Length, diameter of wad, Length from top to the cut mark.
• • • • •
Length, Diameter of neck and body, Weight, Over flow capacity, Light transmission test.
• • •
Thickness of Al foil, Weight at gm / sq. inch, Printing conditions.
• •
Conditions of color printing, Quality of paper,
• •
Checking of spelling and any types of error.
Tubes, Spoon and Dropper • Types of rubbers and droppers, • Measurement about quantity for spoon, • Class of glass for tubes.
INSTRUMENTS / APPARATUS USED IN QC DEPARTMENT There are various types of sophisticated instruments are used for the purpose of quality maintaining. The instruments are SI
NAME OF THE MACHINE
17
QTY (Nos) HPLC – PC based, Binary Gradient 01 Atomic Absorption Spectrometer – PC 01 based FTIR – PC based (IR Prestige -21) 01 UV – visible Spectrometer – PC 01 Vacuum Pump 01 Laminar Air Flow 01 Digital Hardness, Thickness & Diameter 01 Tester Moisture Analyzer 01 PH Meter 01 HPLC – PC based, Isocratic 01 Karl Fischer 01 Dissolution Apparatus 01 Disintegration Apparatus 01 Friability tester 01 Incubator (30º to 70ºC & 0º to 60 ºC)-2 set 02 Digital Autoclave for Microbiology – 85 01 Litres Pharmaceutical Refrigerator 01
18
Electrical Microscope
01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16
MANUFACTURER
ORIGIN
Shimadzu Corporation Shimadzu Corporation
Japan Japan
Shimadzu Corporation Shimadzu Corporation
Japan Japan
Shimadzu Corporation
Japan
01
ROLE OF QC IN PUECHASING RAW MATERIAL • The samples of raw materials from suppliers (demanded by procurement department) are tested by the Q.C department & if the sample meets the specification, them the sample is ready for approval. The approval comes from Q.A department after submission of the Q.C test reports. •
After approval of the sample, the supplier asked for raw material, raw materials are tested, if the quality complies, the procurement department buys the raw material.
•
Raw materials are kept in the quarantine are a during the testing of the supplied sample& after testing if everything complies to the standard demands then it is shifted to the store & labeled as approved.
TEST PERFORMED FOR RAW MATERIALS According to GMP each raw materials should be tested for conformity with specification for identity, strength, purity and quality parameters. The quality control department .of RANGS performs the following tests on raw materials ------• • • • • • • • • • • • • • • •
Appearance Odor Identification- (melting point, UV/ VIS method, IR absorption spectrum method.) Solubility Refractive index Wt.per ml/specific gravity Chloride/bulk density Loss of drying Residue of ignition/sulfated ash Specific rotation/acid value Viscosity/iodine value Saponification value Acidity/alkalinity Oxidizing /reducing agent Microbial count Assay
TEST FOR PACKAGING MATERIAL For ensuring better safety and attractiveness of packaging materials QC department conduct the following tests of packaging materials – LABEL 1. Grain direction: The label is kept on water in a pot and observed that it is properly rolled or not. After a while it will be opened to indicate that it is passed. 2. The printing, the expire date, batch no and other items are checked and compared to a standard one. 3. The color and size are also checked against a standard. CARTOON 1. The color and text are compared with an approved standard. 2. Proper gumming or gluing check 3. Strength of the cartoon is checked in gram/sq. meter 4. Proper locking check 5. Flap cut checking VIALS 1. Alkalinity 2. Thickness 3. Cap diameter
4. Proper aluminum seal FOILS The color, the plastic layer and the thickness are compared with a reference standard. COLLAPSIBLE TUBES a. Texture b. Specification measurement c. Inside lacquering test d. Latex seal check e. Presence of Aluminum seal RUBBER CLOSURE a. pH b. Stickiness c. Toxicity d. Ash content e. Density f. Alkalinity AMPULES: a. Surface and sometimes-total alkalinity b. Thickness c. Height d. Breaking point e. Volume CAP Printing, color, diameter, height etc are checked. After packaging of the product, packed materials such as strips, ampoules, blisters, bottles etc are checked for accuracy. It is not possible to check all the products of a batch. Random sampling on the basis of the following rule checks them √N+1 Where N=no of container After sampling every sample is checked. Usually three types of mistakes are checked——— 1. Critical: this is the problem, which cannot be overlooked. E.g.-DAR No. (Drug administration registration number).If DAR is wrong the whole batch will be discarded. 2 Major: For this type of problem reprocessing is possible. E.g.-spelling mistake. 3. Minor: Simple mistakes which can be overlooked. TEST FOR FINISHED PRODUCT GMP specification a. For each batch of drug product, there should be appropriate laboratory determination of satisfactory conformance to its finished product specification prior to release. b. Drug products failing to meet the established specifications and other relevant quality criteria should be rejected. Reprocessing may be performed if possible but the reprocessed
product should meet all the specification and other quality criteria prior to its acceptance and release. Finished product should be checked in the laboratory by suitable procedures. These tests are designed to determine compliance with specification and hence arc critical factor for the QC department. Each lot of products is tested to ensure identity, quality, purity and potency. Q.A authorizes the releases for further processing based on actual physical, chemical & biological laboratory testing The following tests are performed here for the finished productFOR SOLID DOSAGE FORM o Parameter checked— o Description o Identity o Diameter o Thickness o Uniformity of weight o Average weight o Maximum individual variation o Hardness o Friability o Disintegration time o Assay o Percent stated dose IN PROCESS QC To assure batch-to-batch uniformity and integrity of the products, written procedures describing sample taking, the controls and tests or examinations is conducted on in process products of each batch should be established and followed. Such control is intended to monitor the product yield and validate the performance of the production process that may be responsible for causing variability in the characteristics of in process products. The following in process quality control procedures are adopted IPC for Manufacturing Section: Product Tablet
Tests performed Wt. Variation Friability Disintegration Dissolution Hardness Thickness
Capsule Liquids Sterile products
Wt. variation Moisture content Sealing Bottle volume Over all supervision for all steps performed by the operators whether they complies or not with the SOPs.
ADMINISTRATION The main function of administration is to manage the distribution of the right person in the right position for highest/more benefit or productivity. This department move to reduce the problems or conflicts within the employees. This is called the Transition that may be done positively or negatively. FUNCTION Human Resource Department mainly shows its functions on■ Payroll, ■ Employee relations and welfare, ■ Training, ■ Planning and counseling. This department maintains the direct contact with all the employees working in the■ ■ ■ ■ ■ ■
Laundry, Canteen, Cleaning, Gardening, Security, Transport.
Here direct supervision, controlling and monitoring are maintained. This department has indirect supervision on – ■ ■ ■ ■ ■ ■
Leave, Salary, Provident fund, Gratuity, Medical, LFA (leave, fair and assistance).
HEALTH AND SAFETY MANAGEMENT By keeping environment clean and pollution free RANGS Bangladesh is maintaining a very healthy environment. Also the natural scenario adds boost to the working environment. They provide in house medical facilities through Medical Center and in house Doctors. The medical center is well equipped with systems to manage emergency situations.
In an industrial area Safety is the most important issue and RANGS is providing safety to each sector of the organization. It has a good security system. IMPLEMENTATION OF ADMINISTRATION
Positive Thinking Group Approach Transparent Communication Shared and cared Grievances Practices of Creativity Open door policy
MAINTENANCE DEPARTMENT The engineering department of RANGS proceeds with a group of engineers, technicians and workers. Engineering department is composed of the following section: 1. 2. 3. 4. 5.
Work-shop. Engineering store room. Boiler room. Water distillation plant. Chemical plant – Propanolol hydrochloride. Chloroquine phosphate 6. Central plant A.C. 7. ETP (Effluent Treatment Plant ) The function of this section is to operate the utilities and services in the plant. They also perform the maintenance functions. The utilities and services handled by this section includeo Electricity o Potable or Drinking water o Steam Boiler o Air compressor o HVAC System o Central Vacuum System & o Calibration Department. The following instruments are available in the engineering section.
Power Supply o Generators. Capacity: 600 Kws.
Transformer. Boiler (BYWORTH) Origin- UK
DM Water Plant Origin- Ion Exchange (India) Limited
Air Compressor: Manufacturer - Atlas Copco HVAC system : OUR VIEW The global pharmaceutical industry is currently in a state of flux. Imminent patent expiries, growing generic competition and drug failures are combining to create significant cost issues for pharmaceutical companies, compelling them to cut expenditure on product development without compromising on quality and RANGS never compromises with quality. One of the major challenges facing Pharma companies is that their profit margins do not reflect the constantly increasing investment in drug development. On the one hand, this factor has acted as a key driver for pharmaceutical companies' growing interest in cost-effective excipients. Frost & Sullivan believes that the changing definition of excipients from inactive ingredients to functionally active materials has contributed and will continue to contribute tremendously to bring out success. Biotechnological developments and various emerging protein-based therapies are broadening the definition for excipients products.
UNIQUE FEATURES OF RANGS LIMITED IN TAJGAON DHAKA
During our visit we found huge number of female employees working in RANGS in different positions. RANGS believes in empowerment of female.
All the employees are very helpful and co-operative. Facilities provide by the excellent for the workers and the working environment is friendly. All the workers are efficient enough to carry out their respective duties as they are trained up regularly. All these make workers to work with smiling face.
They provide us food facilities. All machineries and the written procedures (BMR, MI, and PR etc) are validated and calibrated regularly to ensure the best quality of the products.
Internal audit is done all the year round. This helps to improve the performance, fixing the errors.