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Preparing Pharmaceutical QMS Documents Thank you for purchasing the PharmOut pharmaceutical Quality Management System (QMS) documents. This information guide will help you get started on generating the QMS documents using the templates provided.

Preparing Pharmaceutical QMS Documents

Introduction The PharmOut QMS templates are based on ICH Q10 and the PIC/S requirements for GMP but can also be adapted for regional Good Manufacturing Practice (GMP) requirements. Our experience has shown the ISO 9001 framework is an excellent, practical model. ICH Q10 provides a harmonised model for a pharmaceutical QMS throughout product lifecycles and is intended to be used together with regional GMP requirements.

The quality system elements and management responsibilities described in these templates are intended to encourage the use of science and risk based approaches at each lifecycle stage, thereby promoting continual improvement across the entire product lifecycle.

The content of the templates prompts for the requirements of the: 

PIC/S Code of Good Manufacturing Practice, and/or



ICH Pharmaceutical Quality System Q10, and/or



ISO 9001:2008 Quality Management Systems for Pharmaceuticals.

The QMS templates are only a guide and are not intended to cover all circumstances unique to your company. Consequently, they may be altered or additional sections or procedures may be added. PharmOut recommends careful consideration of the relevant compliance standards before removing any sections from the Quality Manual document.

Note: This guidance document does not provide instructions for implementing the processes and procedures required by the relevant quality standard within your company. Should you require this, PharmOut is able to help (refer to How PharmOut can help).

PharmOut QMS support PharmOut offers 2 hours free phone or email support with the purchase of the documents within 12 months of the purchase date. Please quote the reference number included with the document purchase invoice.

Additional support is available upon request if further help is required. Refer to the PharmOut website for contact details (www.pharmout.com.au) or email on info@pharmout.com.au.

© 2009 PharmOut Pty Ltd

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Preparing Pharmaceutical QMS Documents

Managing the QMS files in your system Unzip the files Unzip the document files obtained from PharmOut and save them either to an appropriate network drive or a hard disk. A list of the files that you should have received as part of the QMS document package is listed below.

Document Type

Document Number

Title

File Format

Manual

QM001

Quality Manual

Word

Procedure

QP401

Document Control

Word

Procedure

QP402

Quality System Management

Word

Procedure

QP403

Control of Records

Word

Procedure

QP501

Management Review

Word

Procedure

QP601

Training, Awareness and Competency

Word

Procedure

QP602

Equipment Maintenance

Word

Procedure

QP603

Pest Management

Word

Procedure

QP604

Facility Management

Word

Procedure

QP605

Recruitment and Selection of Personnel

Word

Procedure

QP701

Environmental Monitoring

Word

Procedure

QP702

Order Processing and Review

Word

Procedure

QP703

Change Control

Word

Procedure

QP704

Supplier Evaluation and Monitoring

Word

Procedure

QP705

Sampling

Word

Procedure

QP706

Procurement

Word

Procedure

QP707

Verification of Purchase Materials

Word

Procedure

QP708

Batch Processing Instruction and Recording

Word

Procedure

QP709

Manufacture of Product

Word

Procedure

QP710

Validation of Processes and Equipment

Word

Procedure

QP711

Status Labeling of Incoming Product and Materials

Word

Procedure

QP712

Materials Identification and Traceability

Word

Procedure

QP713

Labeling and Packaging

Word

Procedure

QP714

Measuring and Monitoring Equipment

Word

Procedure

QP715

Analytical Method Validation

Word

Procedure

QP716

Reprocessing of Drug Product and API

Word

Procedure

QP717

Sample Handling in the QC Laboratory

Word

Procedure

QP718

Computer System Validation

Word

Procedure

QP801

Feedback and Customer Satisfaction

Word

Procedure

QP802

Internal Quality Audit

Word

Procedure

QP803

Product Returns

Word

Procedure

QP804

Product Batch Release

Word

Procedure

QP805

Control of Non-Conforming Product

Word

Procedure

QP806

Continuous Improvement

Word

Procedure

QP807

Product Recall

Word

Procedure

QP808

Customer Complaints

Word

Procedure

QP809

Corrective and Preventative Action

Word

Continue next page‌ Š 2009 PharmOut Pty Ltd

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Preparing Pharmaceutical QMS Documents

Continue from previous…

Document Type

Document Number

Title

File Format

Procedure

QP810

Calibration of Balances

Word

Procedure

QP811

Annual Review of Drug Product

Word

Procedure

QPXXX

Blank Procedure

Word

Form

FP401-1

Master List of Controlled Documents

Excel

Form

FP501-1

Quality Management Action Record

Word

Form

FP601-1

Competency Requirements Matrix

Excel

Form

FP601-2

Training Course Record

Form

FP601-3

Training Record Form

Excel Word & Excel

Form

FP603-1

Pest Treatment and Activity Log

Word

Form

FP702-1

Customer Order Form

Excel

Form

FP703-1

Change Control Form

Word

Form

FP709-1

Pre-Manufacture Checklist

Word

Form

FP709-2

Cleaning Regimes for Product Manufacture Checklist

Word

Form

FP710-1

Incident and Deviation Report

Word

Form

FP718-1

Quality Control Laboratory Sample Receipt Log

Word

Form

FP801-1

Audit Register Form

Excel

Form

FP803-1

Calibration Records for Balances

Word

Form

FP805-1

Product Non-Conformance Report

Word

Form

FP809-1

Complaints Register

Excel

Form

FP810-1

Correction and Preventative Action Request

Word

Form

FPXXX

Blank Form Landscape

Word

Form

FPXXX

Blank Form Portrait

Word

Document control during drafting Once drafting begins, PharmOut suggests saving the QMS files with a document control suffix in the file name and in a separate folder to the original files. This ensures that the original templates are always available and helps track draft/review stages. Some examples may include: 

Track the draft version - QM001 Quality Manual_v01a, b, c etc



Track the date of review (1st Jan 2010) – QM001 Quality Manual_010110



Track a reviewer – QM001 Quality Manual_JBloggs



A combination of the above

It is important to maintain consistency in the document control mechanism you decide to use during the drafting process.

Once the QMS documents are completed and are ready to be implemented, save the files according to your document control procedure (QP401) with the document revision number in the file name.

© 2009 PharmOut Pty Ltd

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Preparing Pharmaceutical QMS Documents

Starting the QMS documents QMS document requirements A company requiring GMP and/or ISO compliance must establish, document, implement and maintain a QMS, as well as maintain its effectiveness, in accordance with the required quality standard.

QMS documents require the following elements: 

documented statements of a quality policy and quality objectives



a Quality Manual that includes: -

the scope of the QMS including details of, and justification for exclusions

-

documented procedures for the QMS or reference to them

-

a description of the interactions between the processes of the QMS.



documented procedures required by the compliance standard (if not located within the Quality Manual)



documents needed by the organisation to ensure effective planning, operation and control of its processes



records required by the compliance standard such as evidence of conformity to requirements and the effective operation of the QMS.

Where do I start?

To achieve the above elements, PharmOut recommends that you use the following steps. You may also use the QMS Preparation Checklist at the end of this guide to ensure that the documentation requirements have been met.

1. Identify your company’s key processes, existing procedures, and management and control systems needed for the QMS. 2. Map the key processes so that you understand their sequence and interaction.

The map should highlight what processes and procedures will need to be documented and also ensures that the QMS is structured to reflect the services you supply and the processes and specific practices you use.

3. Draft your Quality Manual using your document map created in Step 2. Use the prompts within the template as a guide to the contents. Include: 

the scope of the QMS, details and justifications of exclusions



the documented procedures established for the QMS



a description of the interaction between the processes of the QMS



the documentation structure of QMS documents.

4. Draft all procedures and forms required for the QMS highlighted in Step 1 and Step 2 using the templates.

5. Ensure the content of all QMS documents are reviewed by appropriate subject matter experts (SMEs).

6. Prepare hard copies of all QMS documents and obtain the appropriate approval as dictated by the compliance standard. © 2009 PharmOut Pty Ltd

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Preparing Pharmaceutical QMS Documents

7. Maintain these QMS documents as described by the relevant QMS procedures.

Using the PharmOut QMS templates The PharmOut QMS templates have been prepared to meet the requirements of the compliance standards for PIC/S GMP, ICH Q10 and ISO 9001:2008.

Document Hierarchy The QMS templates are structured in the following hierarchy.

Document Type

Description

Quality Manual

This is the high level document that provides policy on a company’s processes (that is, how your company’s QMS works). It details:

Procedures



QMS requirements



management responsibilities



management of resources for all aspects of the company



how manufacture will be designed, validated and conducted



customer-related processes



Quality Assurance processes.

Details all procedures required by the company to plan, operate and control its processes. Additional procedures to those supplied with the PharmOut QMS templates can be generated using the Blank Procedure template.

Procedures for smaller/simpler QMS may also be incorporated into the Quality Manual or multiple procedures may be combined (where appropriate).

Forms

Captures records for all data/information required to support or confirm a company’s processes. Additional forms to those supplied with the PharmOut QMS templates can be generated using the Blank Form template. Forms may also be in MS Word or Excel format.

A company may prefer to capture forms either as separate controlled documents or within the appropriate procedure document. Refer to the attachment section at the back of the PharmOut Blank Procedure template as a guide to inserting forms within a procedure.

Note: Additional controlled document types may also be used at the discretion of your company depending on requirements or preferences. These may include: 

work/operating instructions



manuals



lists, logbooks or templates.

These additional document types may be adapted from the PharmOut QMS templates but are not included as part of the QMS document package.

© 2009 PharmOut Pty Ltd

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Preparing Pharmaceutical QMS Documents

Document numbering The QMS templates have been pre-numbered so that the procedures and forms reflect the relevant section of the Quality Manual. The QMS documents have the following numbering convention.

Document Type

Document Number

Quality Manual

QM001

Numbering Convention QM - Quality Manual Note: Typically, there is only one Quality Manual so sequential numbering is not required.

Procedure

QPNXX

QP - Quality Procedure N - Section number from the Quality Manual XX - Next sequential number Example: QP401 is the first procedure associated with Section 4 of the Quality Manual.

Form

FMNXX-Y

FM - Form N - Section number from the Quality Manual XX - Number corresponding to that of referenced procedure.

Y – Next sequential number of forms referenced from the procedure.

Example: FM401-1 is the first form associated with Section 4 of the Quality Manual and Procedure QP401.

This numbering convention may be changed to reflect your company’s QMS requirements.

The Start Here guide also contains guidelines for using MS Word functions to automate document creation and maintenance tasks as well as a comprehensive QMS preparation checklist.

© 2009 PharmOut Pty Ltd

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The Quality Manual

Let’s take a look at some sample pages from the Quality Manual template.

The red text provides instructions and advice to the document author.

Insert Company Logo here

Document ID: QM001

Revision No.: <Rev No>

Quality Manual

Document information, authorship and approvals Author signs to confirm technical content Prepared by:

Job title:

Signature:

Date:

Subject matter expert reviewer signs to confirm technical content Reviewed by:

Job title:

Signature:

Date:

Quality representative signs to confirm document complies with quality management system Authorised by:

Job title:

Signature:

Date:

Document review date

Document is current only if front page has â&#x20AC;&#x153;Controlled copyâ&#x20AC;? stamped in red ink

Page 1 of 24

<Company Name>

Quality Manual Document ID: QM001

Revision No.: <Rev No>

Table of Contents Update the Table of Contents (TOC) during drafting by clicking anywhere on the TOC and pressing F9.

1.

2.

Scope

4

1.1.

General

4

1.2.

Exclusions

5

References

6

2.1.

Regulatory codes and guidelines

6

2.2.

Standards

6

3.

Terms and definitions

7

4.

Quality management system

8

4.1.

General requirements

8

4.2.

Documentation requirements

9

5.

6.

7.

Management responsibility

11

5.1.

Management commitment

11

5.2.

Customer focus

11

5.3.

Quality policy

11

5.4.

Planning

12

5.5.

Administration of the QMS

12

5.6.

Management reviews

14

Resource management

15

6.1.

Provision of resources

15

6.2.

Human resources

15

6.3.

General

15

6.4.

Competence, awareness and training

16

6.5.

Buildings, workspace and associated utilities

16

6.6.

Process equipment

16

6.7.

Supporting services

17

6.8.

Equipment maintenance

17

6.9.

Work environment

17

Product realisation

17

7.1.

Planning for product realisation

17

7.2.

Customer-related processes

17

Document is current only if front page has “Controlled copy” stamped in red ink

Page 2 of 24

<Company Name>

8.

Quality Manual Document ID: QM001

Revision No.: <Rev No>

7.3.

Design and development

18

7.4.

Purchasing

19

7.5.

Production and service operations

20

Measurement, analysis and improvement

21

8.1.

General

21

8.2.

Monitoring and measurement

22

8.3.

Control of non-conformity

22

8.4.

Analysis of data

23

8.5.

Improvement

23

Document is current only if front page has â&#x20AC;&#x153;Controlled copyâ&#x20AC;? stamped in red ink

Page 3 of 24

<Company Name>

Quality Manual Document ID: QM001

Revision No.: <Rev No>

A quality manual is a comprehensive description of your company’s quality management system (QMS) which ensures the conformity of your products to the regulatory requirements you are required to meet.

This quality manual template has a structure that complies with ISO9001:2008 and content that will prepare for compliance to CFR 210 and 211, and ICH Q10 Pharmaceutical Quality System. While populating this manual with your information, reference these regulatory/compliance documents and others such as the Australian Code of Good Manufacturing Practice (GMP). Ensure that your QMS is compliant to these regulations and is detailed in the quality manual.

Additional detail not included in this template may need to be included for unique, company-specific requirements.

1.

Scope 1.1. General 1.1.1. Introduction Company Pty Ltd develops and manufactures fine chemicals and intermediate products used in the manufacture of pharmaceutical (drug substances for human and veterinary use), materials and electronics industries. Company Pty Ltd products are sold ...

Insert product details above as appropriate. Insert your company name in the field above to populate the remainder of the document.

This quality manual:  Addressed the requirements for a QMS (Quality Management System) for the development and manufacture of these products, incorporating management of the life cycle of each product.  Addresses the quality standards used to comply with regulatory requirements where the products are developed, manufactured and distributed.  References relevant policies, procedures and other documents that make up the QMS.  Presents the QMS to customers, suppliers, regulators and other external interested parties, informing them what specific controls are in place to assure quality.

This manual is structured on ISO 9001:2008 with eight sections divided into subsections relating to the main QMS processes. The subsections define general policies and principles of the relevant quality system.

1.1.2. Quality policy Company Pty Ltd is committed to meeting customer requirements and enhancing customer satisfaction by delivering products that meet or exceed relevant quality standards through continual improvement of its products, services and the QMS.

Document is current only if front page has “Controlled copy” stamped in red ink

Page 4 of 24

<Company Name>

Quality Manual Document ID: QM001

Revision No.: <Rev No>

The management team will:  Implement and maintain a formal QMS that conforms to ISO 9001:2008  Ensure the QMS requirements are always met  Review this policy at least every two years to ensure the objectives are appropriate and that it is effective and suitable  Ensure that this policy is communicated and understood by all employees, contractors and suppliers.

1.1.3. Application The QMS described in this quality manual applies to the development, manufacture and distribution of products supplied by Company Pty Ltd.

1.2. Exclusions The QMS described in this quality manual relates to Company Pty Ltd, its products, customer requirements and regulatory obligations.

Company Pty Ltd excludes QMS requirements only if the exclusion:  Does not affect the company’s ability nor remove its responsibility to provide product that meets specified requirements  Does not affect the company’s ability to carry out corrective action  Applies to quality requirements in Section 7 (inclusive) because of its nature, customer requirements and applicable regulatory requirements.

The Quality Manager is responsible for identifying exclusions and proposing these to the Managing Director for exclusion from the scope of the quality system. The evaluation and approval of exclusions is conducted within the framework of management reviews of the QMS. 1.2.1. Identified exclusion There are no exclusions to the QMS... or The following exclusions have been identified: List relevant procedures that are excluded.

Document is current only if front page has “Controlled copy” stamped in red ink

Page 5 of 24

<Company Name>

2.

Quality Manual Document ID: QM001

Revision No.: <Rev No>

References 2.1. Regulatory codes and guidelines Table 1: Regulatory codes and guidelines for this QMS Reference

Title

Pharmaceutical Inspection Convention / Pharmaceutical Inspection Cooperation Scheme (PIC/S) PE 009-8

Guide to Good Manufacturing Practice for Medicinal Products Part II and annexes

US FDA 21CFR Part 210

Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs, General

US FDA 21CFR Part 211

Current Good Manufacturing Practice for Finished Pharmaceuticals

ICH of Technical Requirements for Registration of Pharmaceuticals for Human Use

Pharmaceutical Quality System Q10, Step 4 version

Therapeutic Good Administration

Australian Code of Good Manufacturing Practice for Medicinal Products, 16 August 2002

Add/delete as appropriate

2.2. Standards Table 2: Standard requirements for this QMS Reference

Title

AS/NZS ISO 9000:2008

Quality Management Systems–Fundamentals and Vocabulary

AS/NZS ISO 9001:2008

Quality Management Systems–Requirements

Add/delete as required.

Document is current only if front page has “Controlled copy” stamped in red ink

Page 6 of 24

<Company Name>

3.

Quality Manual Document ID: QM001

Revision No.: <Rev No>

Terms and definitions Table 3: Terms and definitions used in this Quality Manual Term

Definition

Customer complaint

Written, electronic or oral communication that alleges deficiencies related to the identity, quality, safety or performance of a drug product

Pharmaceutical drug substance

An active drug ingredient or precursor of an active drug ingredient which is used - sometimes after further chemical reaction – in association with inactive ingredients to form a finished dosage form.

FDA (Food and Drug Administration)

The government agency that administers the registration of medicinal (and other) products for sale in the United States

GMP (Good Manufacturing Practices)

Accepted manufacturing practices in the pharmaceutical industry. The FDA refers to cGMP; the ‘c’ meaning current

ICH (International Conference on Harmonisation)

The international body set up to harmonise legislation and regulations governing the International Pharmaceutical industry

ISO (International Organisation for Standardisation)

The international body that set and manages a range of international benchmark standards, including the one to which this manual is written

TGA (Therapeutic Goods Administration)

The government agency that administers the registration of medicinal (and other) products in Australia

Conformity

Meets standards or specifications

Add/delete as required.

Document is current only if front page has “Controlled copy” stamped in red ink

Page 7 of 24

<Company Name>

4.

Quality Manual Document ID: QM001

Revision No.: <Rev No>

Quality management system 4.1. General requirements This QMS is designed as a system of interrelated processes. It sets out the processes and procedures that together will provide the mechanisms required to implement the Quality Policy (refer to Section 1.1.2).

A separate Quality Policy may be generated if required, although typically this is incorporated into the Quality Manual in Section 1.1.2.

The systems’ main activities are defined as the Quality System Processes (QSPs) and are grouped into categories (Figure 1, A-F) with 16 sub-processes (1-16).

Figure 1: QSP map Product info, quotes & orders

A. CUSTOMER REQUIREMENTS CUSTOMERS

Customer Communication

12 Human Resources 13 Plant, facility & equipment 14 Information resources (document control) 15 Measuring/monitoring devices 2 Product development 3. Production & quality planning

10 Management policies, planning & commitments

E. RESOURCE MANAGEMENT

11 Management review

4. Purchasing & receiving B. PRODUCT REALISATION

D. MANAGEMENT RESPONSIBILITY F. (16) CONTINUAL IMPROVEMENT Corrective & Preventive Action

C. MEASUREMENT, ANALYSIS & IMPROVEMENT

7 Monitoring of manufacturing processes measurement of product 6 Labelling, packaging, shipping, distribution

8. Monitoring/measurement of QMS (internal audits) 9 Monitoring customer

CUSTOMERS

Note: Detailed process descriptions are provided in the Quality System Process Matrix.

Document is current only if front page has “Controlled copy” stamped in red ink

Page 8 of 24

<Company Name>

Quality Manual Document ID: QM001

Revision No.: <Rev No>

Where applicable, delete the contents of Figure 1 and insert a customised diagram for your company.

The Quality System Process Matrix may be a separate document listing the relationship of key compliance processes and sub-processes. This could be controlled documentation of the document map generated during the drafting stage of the QMS (refer to the How to Prepare QMS Documents guide supplied by PharmOut with the QMS templates). However, a QMS could also use the documents tabled in Section 4.2.4.

Ensure accurate cross referencing of names and locations for the Quality System Process Matrix used by your company.

4.2. Documentation requirements 4.2.1. General Each quality system sub-process is controlled by documentation (refer to Table 4). The QMS at Company Pty Ltd contains appropriate documents that ensure effective operation and control of processes and record keeping, and include this quality manual and the quality policy.

The documentation describes:  What, when and how it is to be done  The resources required  Who is responsible 4.2.2. Quality manual This quality manual details the:  Quality policy of Company Pty Ltd  Process by which the policy will be implemented  Organisational structure of Company Pty Ltd  Procedures for the QMS  Responsibilities of the Managing Director to achieve compliance 4.2.3. Control of documents All documents required by the QMS are controlled. Approval of, and changes to, these documents is the responsibility of the Quality Manager.

The following processes are in place:  Unique identification of controlled documents  A review and approval (and if necessary a re-approval) process  Identification of personnel to approve, issue and register controlled documents  Allocation and distribution of controlled documents  Control of changes to controlled documents  Control, removal and archival of obsolete documents, including a system to prevent their unintended use  Identification and management of documents produced by external organisations used by the Company Pty Ltd during GxP procedures Document is current only if front page has “Controlled copy” stamped in red ink

Page 9 of 24

<Company Name>

Quality Manual Document ID: QM001

Revision No.: <Rev No>



Maintenance of a master file of all current and superseded controlled documents (whether internal or external) All superseded controlled documents must be clearly marked ‘superseded’ to avoid confusion.

Copies of master documents are created only when specifically required. Uncontrolled copies may be made provided these are clearly marked ‘Uncontrolled’.

List relevant procedures related to the document control function.

4.2.4. Control of quality records All records containing compliance evidence of product quality requirements are retained.

These are retrievable in a readable form, uniquely identifiable and legible. A procedure is defined for the identification, storage, protection, retrieval, retention and deposition of records.

List relevant procedures related to the control of quality records such as forms, logs, batch records etc or other quality records.

Table 4: Documentation controlling each sub-process Confirm documents listed are in use for your system. Include additional document references that you have generated to describe unique, company-specific procedures.

Sub-processes

Related document no. and title

Product information, quotations and orders

QP702 Procedure: Order processing and review

Product development

QP710 Procedure: Validation of processes and equipment QP715 Procedure: Analytical method validation QP718 Procedure: Computer systems validation

Production and quality planning

QP704 Procedure: Supplier evaluation and monitoring

Purchasing and receiving

QP705 Procedure: Sampling QP706 Procedure: Procurement QP707 Procedure: Verification of purchased materials

Production

QP701 Procedure: Environmental monitoring QP703 Procedure: Change control Qp705 Procedure: Sampling QP708 Procedure: Batch processing instruction and recording QP709 Procedure: Manufacture of product QP712 Procedure: Materials identification and traceability QP716 Procedure: Manufacture of drug product and APIs QP717 Procedure: Sample handling in the QC lab

Labelling, packaging, shipping and distribution

QP711 Procedure: Status labelling of incoming materials and finished product QP713 Procedure: Labelling and packaging QP714 Procedure: Storage and distribution

Monitoring and measurement of products

QP804 Procedure: Drug product batch release QP805 Procedure: Control of non-conforming product QP811 Procedure: Annual review of drug product

Document is current only if front page has “Controlled copy” stamped in red ink

Page 10 of 24

<Company Name>

Quality Manual Document ID: QM001

Revision No.: <Rev No>

Sub-processes

Related document no. and title

Monitoring and measurement of quality management systems (internal audits)

QP802 Procedure: Internal quality audits

Monitoring customer feedback and satisfaction

QP801 Procedure: Feedback and customer satisfaction QP803 Procedure: Product returns QP807 Procedure: Product recall QP808 Procedure: Customer complaints

Management policies, planning and commitments

QP402 Procedure: Quality system management

Management review

QP501 Procedure: Management review

Human resources

QP601 Procedure: Training, awareness and competency QP605 Procedure: Recruitment and selection of personnel

Plant, facility and equipment

QP602 Procedure: Equipment maintenance QP603 Procedure: Pest management QP604 Procedure: Facility maintenance

Information resources (document control)

QP401 Procedure: Document control QP403 Procedure: Control of records

5.

Measuring and monitoring devices

QP810 Procedure: Calibration of balances

Continual improvement (Corrective and preventative action)

QP806 Procedure: Continual improvement QP809 Procedure: Corrective and preventative actions

Management responsibility 5.1. Management commitment Company Pty Ltd’s Managing Director will ensure the company is continually striving to meet its quality objectives by:  Communicating formally and regularly to the organisation the importance of meeting customer, legal and regulatory commitments  Establishing and maintaining this QMS  Ensuring the availability of resources  Conducting regular quality audits and management reviews

5.2. Customer focus Customer requirements will be determined as per Section 7.2 and monitored as per Section 8.2.

Ensure that section numbering is correct prior to approving this document.

5.3. Quality policy The Managing Director will ensure that the quality policy: Document is current only if front page has “Controlled copy” stamped in red ink

Page 11 of 24

<Company Name>

    

Quality Manual Document ID: QM001

Revision No.: <Rev No>

Is appropriate to the purpose of Company Pty Ltd Commits to meeting these quality requirements and to continual improvement Has a suitable framework to establish and review quality objectives Is communicated to, and understood by, appropriate parts of the company Is reviewed for continued suitability

5.4. Planning 5.4.1. Quality objectives The quality objectives of Company Pty Ltd are to:  Implement the quality policy  Meet requirements for products and processes  Improve the QMS and quality performance Quality objectives are established during management reviews of the QMS. Management reviews can also initiate and monitor projects for achieving quality objectives.

5.4.2. Quality management system planning Quality system processes are planned to ensure that the system is appropriate for its intended purpose, and that it is effective and efficient. The purpose of the quality system is to:  Comply with the quality policy  Ensure and demonstrate the company’s ability to provide products that consistently meet customer and applicable regulatory requirements  Ensure a high level of customer satisfaction  Facilitate continual improvement  Comply with the requirements of the ISO 9001:2008 standard and applicable regulatory requirements as listed in Section 2.

The output of quality system planning comprises this quality manual, associated operational procedures and referenced documents.

Changes to the QMS may be in response to changes in product, process, capacity, operational or organisation and are made to improve the effectiveness and efficiency of the QMS. Changes are discussed during management reviews of the QMS. List relevant procedures as appropriate. Ensure table number is correct prior to approving this document.

5.5. Administration of the QMS 5.5.1. General The QMS is to be effectively administered and controlled.

5.5.2. Responsibility and authority Refer to Figure 2 for the organisational structure that directs, manages and delivers the QMS. Document is current only if front page has “Controlled copy” stamped in red ink

Page 12 of 24

<Company Name>

Quality Manual Document ID: QM001

Revision No.: <Rev No>

Put organisation structure here, ensuring figure numbers are correct prior to approving this document.

Figure 2: Organisational structure

5.5.3. Management representative Table 5 details individual responsibilities responsible for the establishing, implementing and maintaining the QMS. Table 5: Roles and responsibilities Role

Responsibilities

Managing Director

Ensure all personnel are nominated to manage, perform and to supervise activities within the quality system Ensure that responsibilities of staff are clearly defined Nominate a quality management representative Review the quality system at planned intervals Assess opportunities for improvement of the quality system Identify the need to change the quality system

Quality Manager

Establish, develop, implement and maintain the QMS Manage the quality process Report to the Managing Director on the performance of the QMS Promote awareness of the customer’s requirements and this QMS throughout the organisation Approve quality related documentation Verify the implementation of corrective and preventative processes Identify deficiencies relating to the quality system Initiate preventative and corrective actions to prevent reoccurrence of nonconformances

Production Manager

Identify training requirements Train staff, visitors, contractors and if necessary suppliers, including induction of new staff in the requirements of the QMS Develop and approve controlled documentation Implement preventative and corrective actions Address and resolve technical problems Manage equipment and product related issues Update staff training plans and registers to reflect current procedures and policies

Amend as required.

5.5.4. Internal communication The Managing Director ensures that there is regular, scheduled and effective communication by all staff and contractors at Company Pty Ltd regarding the quality system. This process is managed by the Quality Manager and comprises:  Communication by managers to the organisation of: The company’s quality policy and objectives Document is current only if front page has “Controlled copy” stamped in red ink

Page 13 of 24

<Company Name>



Quality Manual Document ID: QM001

Revision No.: <Rev No>

Instructions on how to implement and use the quality system Information on effectiveness of and any deviations from the quality system Communication by the organisation to managers of: Information and data regarding quality performance Effectiveness of the quality system

5.5.5. Quality manual This Quality Manual has been established and will be maintained to:  Describe the scope of the QMS including exclusions  Provide reference to documented procedures  Describe the processes included in the QMS  This manual is controlled as part of the documentation control process 5.5.6. Control of documents All documents required for the QMS are controlled and managed under the following procedures. These procedures ensure documents are:  Approved for adequacy before issue and use  Regularly reviewed, updated as necessary and re-approved  Identified for current revision status  Available in current versions at points of use  Are legible and easily identifiable  Distributed in a controlled fashion  Identified as external documents and similarly controlled  Are withdrawn from use if obsolete and identified and stored appropriately.

List relevant procedures or refer to a previous table if the same references.

The Quality Manager has responsibility for ensuring that documents, reports and records are distributed to appropriate departments and that information and data about quality performance and the effectiveness of the quality system are collected and reported to the Managing Director.

5.5.7. Control of records Records of activities carried out under the authority of procedures are controlled. They are managed according to...

List relevant procedures

5.6. Management reviews 5.6.1. General Management review provides the process for the organisation to report on the status of quality-related issues and activities and for managers to formulate and communicate actions to change and/or improve the QMS. Document is current only if front page has “Controlled copy” stamped in red ink

Page 14 of 24

<Company Name>

Quality Manual Document ID: QM001

Revision No.: <Rev No>

These reviews are performed at least every two years. The process is managed according to...

List relevant procedures

5.6.2. Review input The QMS review takes into account:  Findings of audits carried out since the last management review  Customer feedback  Changes in policy and standards  Changes in work practices and organisational structures  Status of corrective and preventative actions  Follow up on previous management review actions  Other changes that could affect the QMS 5.6.3. Review output The output of the QMS review details actions related to:  Improving the QMS and associated processes  Improving product for customer requirements  Implementing resources required to implement any improvements.

QMS reviews are documented and logged within the quality system. Resulting changes to QMS systems are captured via the change control or corrective and preventative action process. The following procedures manage these processes: List relevant procedures

6.

Resource management 6.1. Provision of resources The Managing Director of Company Pty Ltd ensures that adequate resources are available to maintain and improve the quality systems, and ensure customer satisfaction.

6.2. Human resources Add details about human resources with respect to the QMS.

6.3. General All personnel have the appropriate education, training, skills and experience to perform their duties.

Document is current only if front page has “Controlled copy” stamped in red ink

Page 15 of 24

<Company Name>

Quality Manual Document ID: QM001

Revision No.: <Rev No>

6.4. Competence, awareness and training It is the company policy to:  Assess resource needs  Employ personnel (including consultants and contractors) with appropriate qualifications, skills and experience  Provide ongoing training to ensure that personnel retain a high level of expertise in their field(s)  Maintain up-to-date training plans for all personnel  Maintain records of training received Departmental managers will assess and identify training requirements. Methods used will include on-the-job training, discussion groups and where required, formal in-house training or external courses.

Means of assessment may include interviews or supervisor evaluation of performance.

Appropriate records, resumes, job descriptions and training logs are maintained. The following procedures manage this process: List relevant procedures

6.4.1. Infrastructure The facilities are located at... company address... and include premises, services and process equipment that has been designed and installed in accordance with applicable standards and is suitable to support the QMS.

6.5. Buildings, workspace and associated utilities Infrastructure and facilities, such as buildings, workspaces and associated utilities are appropriate and properly maintained to achieve conformity to product requirements.

Departmental managers are responsible for identifying the needs and requirements for new and/or modification/repair of existing infrastructure and facilities in their departments.

Requests for changes and/or expansions of facilities are given to the Managing Director for review and approval.

Regular maintenance of buildings and facilities is performed and includes regular scheduled maintenance of systems, HVAC air conditioning, applicable services, and cleaning. Repairs to buildings and other such facilities are carried out as needed.

The Production Manager is responsible for coordinating and managing maintenance contracts.

List relevant procedures with respect to maintaining the facilities, buildings & utilities.

6.6. Process equipment Procurement of new and/or modification of existing process equipment (including hardware and software) is planned in conjunction with development of manufacturing processes, as defined in Section 7.1.

Ensure that section number is correct prior to approving this document.

Document is current only if front page has “Controlled copy” stamped in red ink

Page 16 of 24

<Company Name>

Quality Manual Document ID: QM001

Revision No.: <Rev No>

6.7. Supporting services Supporting services required by Company Pty Ltd include transportation, communication and IT services. Specifically:  Transportation services are purchased from parcel delivery, courier services and trucking or other approved transport companies  Communication services are provided by telephone, wireless and internet access companies  Installation, management and operation of IT systems, infrastructure and applications List relevant procedures.

6.8. Equipment maintenance Key process equipment, machines, hardware and software are regularly maintained in accordance with approved maintenance plans specified by equipment manufacturers, engineering or responsible departmental managers.

List relevant procedures.

6.9. Work environment The company determines and manages the work environment to achieve product conformity by the application of appropriate environmental requirements and providing facilities that supply them. OHS&E requirements are managed by the Operations Manager.

7.

Product realisation 7.1. Planning for product realisation Before manufacture commences, planning of the product realisation is completed and includes:  Defining the quality objectives and requirements for the product  Establishing written batch process instructions  Training staff in production methods  Validation, verification, qualification, inspection, monitoring and testing activities  Detailing in-process tests required in the batch processing instructions  Documenting all of the above to demonstrate conformance to the QMS

7.2. Customer-related processes 7.2.1. Determining customer requirements The company determines customer requirements by identifying the following:  Product, accompanying documentation and delivery date

Document is current only if front page has “Controlled copy” stamped in red ink

Page 17 of 24

<Company Name>

 

Quality Manual Document ID: QM001

Revision No.: <Rev No>

Product requirements not specified by the customer but required in order to fulfil customer requirements The legal and regulatory requirements of the product for the territory in which it is to be sold

7.2.2. Review of requirements related to the product The company reviews the requirements of the product prior to commitment to supply.

These reviews ensure:  The product requirements are defined  Differences in order requirements are resolved  The product can be supplied to the time, budget and quality requirements 7.2.3. Customer communication The company has established and implemented arrangements for the communication with customers in relation to product information, enquiries, handling of contracts, customer feedback, complaints and recall.

List relevant procedures with respect to customer communication.

7.3. Design and development 7.3.1. Design and development planning Each product is developed to an agreed development plan. The plan determines:  The design and development stages  The review, verification and validation appropriate to each stage  Personnel responsible for each stage 7.3.2. Design and development inputs The requirements for development of a product are determined prior to commencement of development activities and are derived from any of the following:  Manufacture of previous products  Product specification  Regulatory codes and guidelines (listed in Section 2)  Pharmacopoeia  Previous validation activities  Customer requirements List relevant procedures with respect to the design and development inputs. Ensure table number is correct prior to approving this document.

7.3.3. Design and development outputs Products are considered “developed “when they:  Meet the input requirements  Provide appropriate information for purchasing, production and service provision Document is current only if front page has “Controlled copy” stamped in red ink

Page 18 of 24

<Company Name>

   

Quality Manual Document ID: QM001

Revision No.: <Rev No>

Contain or reference product acceptance criteria Specify the characteristics of the product for its safe and proper use Use validated manufacturing processes Have obtained regulatory approval to market from the appropriate regulatory authority(ies)

7.3.4. Design and development review The company reviews the design and the development of the product via:  Project report meetings and reviews  Review of the product specifications  Review of scaled–up product batch manufacture A review is conducted at each design and development stage to verify the product meets the specification appropriate for that stage of development. All reviews are documented.

7.3.5. Design and development verification Transfer of product manufacture to production includes technology transfer, verification and scale-up to production quantities of the final product.

Product and process acceptance criteria are set so that they can be measured to assure product quality.

7.3.6. Design and development validation Validation of selected product is performed using approved test plans, test protocols and checklists as described in the Company Pty Ltd validation procedures. Validation activities are performed prior to delivery or implementation of the product and records are maintained.

List relevant procedures with respect to design/development validation.

Ensure that your QMS validation/verification covers all equipment, computer systems and parts of the facility that impact product quality (GxP) and/or safety, and describes a procedure to determine that impact (GxP versus non-GxP). PharmOut is able to assist your company in determining an appropriate validation approach suited to your company’s needs.

7.3.7. Control of design and development changes Design and development changes, including changes to the product specification, acceptance criteria or manufacturing process are captured using the change control process.

List relevant procedures with respect to control of design/development changes.

7.4. Purchasing 7.4.1. Purchasing process Company Pty Ltd ensures that purchased product and materials conform to specified purchase requirements by internal and external inspections and/or qualification of received goods.

Document is current only if front page has “Controlled copy” stamped in red ink

Page 19 of 24

<Company Name>

Quality Manual Document ID: QM001

Revision No.: <Rev No>

The ability of suppliers to meet the company’s requirements determines the level of control and supervision in place. Each supplier is evaluated and selected on their ability to meet the company’s requirements. Where necessary, a risk-based approach is used to determine the level of control.

List relevant procedures with respect to the purchasing process.

7.4.2. Purchasing information Company Pty Ltd ensures that the purchased product conforms by providing relevant documentation to the supplier including relevant specifications, procedures and processes to determine conformance.

These documents are reviewed and approved by the company before release to the supplier.

7.4.3. Verification of purchased product Company Pty Ltd ensures that the purchased product conforms by inspecting and testing all supplied materials. Testing and inspection are performed to approved specifications and procedures.

List relevant procedures with respect to verifying the purchase product.

7.5. Production and service operations 7.5.1. Control of production and service provision Company Pty Ltd controls production and service operations through the provision of:  Batch processing instructions  Product specifications  Suitable process equipment  Monitoring and measuring devices for critical product parameters  Release, delivery and post delivery activities.

List relevant procedures with respect to controlling production/service provision.

7.5.2. Identification and traceability The product, raw materials and equipment are uniquely identified and tracked through all stages of the process.

List relevant procedures to identification and tracking of product, raw materials and equipment.

7.5.3. Customer property Company Pty Ltd will exercise proper care with customer property, including intellectual property, while in use by or under the control of the company. Customer property is uniquely identified, protected and maintained as per customer requirements. Deviations, loss or damage is formally recorded and reported to the customer.

Document is current only if front page has “Controlled copy” stamped in red ink

Page 20 of 24

<Company Name>

Quality Manual Document ID: QM001

Revision No.: <Rev No>

7.5.4. Preservation of product During internal processing and final delivery to the customer, Company Pty Ltd will ensure adequate handling, storage, labelling and protection for all materials to:  Preserve quality  Safeguard from loss or theft  Safeguard against damage or alteration List relevant procedures to preserving the product

7.5.5. Validation of product Validation of processes is required to assure conformity of product to required specifications when this is not verified during the manufacture of each batch. Examples include mixing or stirring time or speed to assure homogeneity of product, heating time, filtration procedures to assure the sterility or clarity of product.

Products manufactured by Company Pty Ltd will be manufactured using validated process when the resulting output of the process cannot be verified by subsequent measurement or monitoring.

List relevant procedures detailing the validation approach of the QMS.

7.5.6. Control of monitoring and measuring devices To provide evidence of conformity of the product, Company Pty Ltd has installed monitoring and measuring devices. These monitoring and measuring devices are defined during the design, development and qualification of the facility.

To ensure continual compliance, these systems are:  Calibrated at specified intervals to traceable standards  Labelled with calibration status  Where possible, fitted with tamper evident systems  Regularly maintained  Protected from deterioration and mishandling List relevant procedures that detail the control of monitoring/measuring devices.

8.

Measurement, analysis and improvement 8.1. General In order to continually improve the effectiveness of the QMS, Company Pty Ltd has implemented a review system to monitor, measure, analyse and improve the QMS.

Document is current only if front page has “Controlled copy” stamped in red ink

Page 21 of 24

<Company Name>

Quality Manual Document ID: QM001

Revision No.: <Rev No>

8.2. Monitoring and measurement 8.2.1. Customer satisfaction The company actively monitors customer satisfaction via product complaints and customer feedback. Customer satisfaction reports are assessed annually to determine if any actions are required.

List relevant procedures with respect to customer satisfaction.

8.2.2. Internal audit The company conducts periodic internal audits on its quality system to confirm that it complies with the requirements and is operating effectively. Audits are conducted to seek objective evidence to provide this assurance.

Audits are performed according to the status and importance of the activities and areas, and take into consideration performance in previous audits. The audit scope, frequency, criteria and methods are defined and documented.

Company Pty Ltd addresses any deficiencies in a timely manner.

List relevant procedures with respect to internal audits.

8.2.3. Monitoring and measurement of processes QMS processes are monitored by a variety of approaches and techniques, as appropriate for a particular process and its importance. These include:  Conducting internal audits of the QMS  Monitoring trends in corrective and preventive action requests  Measuring product conformity  Monitoring other quality performance data and trends  Monitoring customer satisfaction.

List relevant procedures detailing monitoring and measuring processes.

8.2.4. Monitoring and measurement of product Company Pty Ltd measures the characteristics of a product to verify that product requirements and specifications have been met using the following procedure: List relevant procedures detailing monitoring and measuring product.

8.3. Control of non-conformity The review and disposition of non-conforming products and raw materials is the responsibility of the Quality Manager. When a non-conforming product is identified it is evaluated to determine whether it should be reworked, accepted or rejected.

To prevent a non-conformity reoccurring, an investigation into the cause is undertaken.

This is documented via the corrective and preventative actions procedure and recommendations are followed up to ensure that action has been taken.

Document is current only if front page has “Controlled copy” stamped in red ink

Page 22 of 24

<Company Name>

Quality Manual Document ID: QM001

Revision No.: <Rev No>

When processes affecting product conformity are outsourced, special controls are implemented to ensure these processes meet specified requirements. Such controls include, as appropriate:  Evaluation and pre-qualification of suppliers  Assessment of suppliers manufacturing processes  Assessment of contractor's quality system  Assessment of customer (contract) requirements  Monitoring of supplier quality performance  Requirements for process control, inspection, testing or other records demonstrating product conformity  Verification of the supplied product The company takes full responsibility to ensure outsourced processes conform to all customer and regulatory requirements.

List relevant procedures with respect to the control of non-conformity.

8.4. Analysis of data Data is collected through quality reviews, non-conformances, manufacturing process trend data, customer complaints and customer satisfaction surveys to determine the conformance of the QMS.

8.5. Improvement 8.5.1. Continual improvement Requests for improvements in product realisation are identified via the quality objectives, audit results, analysis of data, corrective and preventative actions and management review.

All changes are managed via the change control procedure.

List relevant procedures to implementing continual improvement.

8.5.2. Corrective action When a non-conformance is observed, an investigation is undertaken to determine the cause and identify the corrective action to ensure it does not re-occur.

List relevant procedures that detail the corrective action process.

8.5.3. Preventative action When a deviation is observed, an investigation is undertaken to determine the cause and identify the preventative action required to avoid product non-conformance.

List relevant procedures for implementing preventative action.

DOCUMENT END Document is current only if front page has “Controlled copy” stamped in red ink

Page 23 of 24

Quality Manual

<Company Name>

Document ID: QM001

Revision No.: <Rev No>

Document Information Revision History Revision

Modified by

Description of Change

01

Complete the above fields for each revision of this document. Ensure that there is sufficient description of changes so that the change history of this document can be followed.

Additional columns can be added to include document/change tracking numbers generated by your company’s systems if required (eg. change control).

Associated forms and procedures Doc. No.

Document Title

List all controlled procedural documents referenced in this Quality Manual (for example, policies, procedures, forms, lists, work/operator instructions etc) Associated records Doc. No.

Document Title

List all other referenced records in this Quality Manual. For example, regulatory documents, in-house controlled documents (such as batch record forms, reports, methods, protocols), compliance standards etc.

Document is current only if front page has “Controlled copy” stamped in red ink

Page 24 of 24

Example procedure template

To give you an idea of what the templates contains, hereâ&#x20AC;&#x2122;s the Training, Awareness and Competency procedure template that is included in the pack..

The templates contain all the content that is likely to be common between companies.

You modify the existing content to suit your company and add more to cover topics that are unique to your situation.

Document ID: QP601

Insert Company Logo here

Revision No.: 01

Procedure: Training, Awareness and Competency

Document information, authorship and approvals Author signs to confirm technical content Prepared by:

Job title:

Signature:

Date:

Subject matter expert reviewer signs to confirm technical content Reviewed by:

Job title:

Signature:

Date:

Quality representative signs to confirm document complies with quality management system Authorised by:

Job title:

Signature:

Date:

Document review date

Document is current only if front page has â&#x20AC;&#x153;Controlled copyâ&#x20AC;? stamped in red ink

Page 1 of 8

<Company Name>

Training, Awareness and Competency Document ID: QP601

Revision No.: 01

Table of Contents 1.

Purpose

3

2.

Application

3

3.

Responsibilities

3

4.

Procedure

3

4.1.

General

3

4.2.

Training records

4

4.3.

Competence and training requirements

4

5.

4.3.1. Awareness programs

4

4.3.2. Training

4

4.3.3. Internal communications

4

4.4.

4

Awareness programs

4.4.1. Safety training

4

4.4.2. Use of company-wide systems

5

4.4.3. External training

5

4.4.4. Self-directed study

5

4.5.

5

Training

4.5.1. On the job training

5

4.6.

Competence requirements matrix

6

4.7.

Training effectiveness evaluation

6

4.8.

Internal Communication

6

Heading 1

8

5.1.

Heading 2

8

5.1.1. Heading 3

8

HEADING 4

8

Document is current only if front page has “Controlled copy” stamped in red ink

Page 2 of 8

Training, Awareness and Competency

<Company Name>

1.

Document ID: QP601

Revision No.: 01

Purpose This procedure describes a system, provides instructions and assigns responsibilities for identifying training needs for personnel at <Company Name>, providing the necessary training and awareness programs and maintaining training records.

2.

Application This procedure applies to all training and awareness programs for all operations relating to the development, manufacture, packaging, testing, dispatch and after-sales care of products covered by the <Company Name> Quality Management System (QMS).

3.

Responsibilities Amend this section to reflect the organisational structure in your company Role Managing Director

Ensures appropriate communication processes are implemented throughout <Company Name>.

Quality Manager

Maintains the storage and control of training records.

Managers

Ensures all staff and contractors are trained and have the appropriate combination of education, training and experience to competently perform the tasks assigned to them; and that they have an up-to-date training record.

All employees

4.

Responsibility



Ensure they have full understanding and requisite experiences to competently carry out the tasks assigned to them



Keep their training records up to date.

Procedure 4.1. General The objectives of the training program are to ensure that:  employees possess the necessary knowledge to perform their assigned tasks  they are familiar with requirements of the QMS relevant to their job functions Awareness programs focus on:  understanding the importance of customer requirements  the relevance of an individual’s contribution to meeting requirements  achieving the company’s quality policy and objectives.

Internal communications are to ensure that product quality and pharmaceutical quality system issues are escalated to appropriate levels of management in a timely manner.

Document is current only if front page has “Controlled copy” stamped in red ink

Page 3 of 8

<Company Name>

Training, Awareness and Competency Document ID: QP601

Revision No.: 01

4.2. Training records Participation in the employee training is recorded and these records are stored centrally and maintained by the quality manager to Procedure QP403: Control of Records.

4.3. Competence and training requirements 4.3.1. Awareness programs Awareness programs are provided to all employees, regardless of their function or position.

Programs include orientation, rules and regulations, quality management systems, safety and other company-wide systems. The Managing Director is responsible for determining requirements and identifying training and awareness needs for company-wide programs.

4.3.2. Training Training is focused on the skills required for employees to perform their assigned tasks, e.g. operate equipment, run processes, carry out inspection and testing, analytical/statistical techniques, etc. Individual managers (including the Managing Director) are responsible for determining competence requirements, identifying training needs and establishing appropriate training programs.

Competence requirements and training needs for specific positions and tasks are defined in the Form FP601-1: Competency Requirements Matrix.

Training needs of individuals are determined on the basis of their education, skills and experience and in light of the tasks they are required to perform. Re-evaluation of competencies is to be undertaken at least annually.

4.3.3. Internal communications A system of internal communications is provided to ensure that the flow of information throughout <Company Name> is timely and effective.

4.4. Awareness programs The Managing Director provides orientation training to all new and existing employees and contractors. This training explains:  background to and objective of the company  the company’s administrative arrangements, safety requirements and facilities  the company’s products and processes with emphasis on critical quality characteristics and consequences of a failure  an overview of the company's QMS  discussion of the company’s quality policy  an explanation of how individual employees can contribute to maintaining and improving the QMS 4.4.1. Safety training Employees are trained in safe work practices, use of personal protective equipment and emergency procedures, etc.

Document is current only if front page has “Controlled copy” stamped in red ink

Page 4 of 8

<Company Name>

Training, Awareness and Competency Document ID: QP601

Revision No.: 01

4.4.2. Use of company-wide systems Groups of employees are trained in the use of interdepartmental systems such as parts and materials numbering, retrieval and creation of documents and records. Training is provided by the person or department responsible for the system.

4.4.3. External training <Company Name> may provide resources such as leave, costs and travel facilities for employees to participate in seminars, conferences and other forms of external training.

Requests for external training are evaluated by the Managing Director.

4.4.4. Self-directed study <Company Name> encourages employees to read professional reports, magazines and books. Requests for magazines and books are evaluated and processed by individual departments. Self-directed study is considered in formal recognition of skills as an alternative form of training. Where appropriate, self-study is recorded.

4.5. Training Personnel only undertake those tasks for which they have been trained and have sufficient education and experience.

All training is recorded. Each person has an individual training record.

Managers are responsible for providing the necessary training to ensure personnel are skilled, capable and competent to perform their duties.

Training is undertaken in a variety of ways:  On the job training  Classroom style sessions  Individual reading.

4.5.1. On the job training When practice is required to ensure staff are competent, they work under the supervision of an experienced staff member.

On-the-job training is recorded including:  the nature of the task  its scope  duration  the success, or otherwise, of the training  name and signature of the person supervising the training.

The company maintains individual training records documenting which employees are trained for which tasks (refer Section 5 of this procedure).

Experienced employees, who have been performing their functions for at least six months, may have their competence formally confirmed by their supervisor, without further training.

This confirmation is documented in writing on their training record.

Employees who fail to perform satisfactorily, or fail the training assessment, are provided with additional or repeat training.

Document is current only if front page has “Controlled copy” stamped in red ink

Page 5 of 8

<Company Name>

Training, Awareness and Competency Document ID: QP601

Revision No.: 01

4.6. Competence requirements matrix The company’s Competency Requirements Matrix is to be maintained. This is especially applicable to manufacturing processes, materials handling, packaging, monitoring, measurement and other functions related to product quality.

Form FP601-1: Competency Requirements Matrix lists jobs and positions in each department and specifies education, training and experience requirements.

Form FP601-3: Individual Training Record when completed lists each person’s competency description and what training is required (and has been undertaken) to fulfil this competency.

The Competency Requirements Matrix is maintained by department managers. Individual training records are maintained by each employee.

4.7. Training effectiveness evaluation The following methods and approaches may be used for evaluating the effectiveness of training provided.

Training Evaluation

Description

Follow-up evaluation of individual employees

Following training, employees are evaluated by their supervisors to assess whether the particular training has achieved its objectives and whether the employee is sufficiently competent in the new skill. Results of this evaluation are recorded and are kept together with the original training record.

Review performance in areas related to particular training

When groups of employees are trained in safety, emergency procedures or interdepartmental systems, training can be evaluated by comparing statistical performance data from before and after the training, e.g. effectiveness of safety training can be measured by tracking rates of workrelated accidents.

Correlation of training with non-conformities and system failures

Training and competency are considered when investigating causes of nonconformities. If inadequate training is identified as a cause, determine which areas of training are deficient. Training must then be reviewed and improved, as appropriate, and staff retrained with the revised presentation.

Global evaluation of training by management review

Training and awareness programs and their effectiveness are evaluated by management reviews. This includes presentation and discussion of data correlating quality performance in particular areas with specific training and awareness programs. QP501 Procedure: Management Review defines this process.

4.8. Internal Communication A system of internal communication is to be set up to:  ensure all levels of the company are kept regularly informed and briefed on pharmaceutical quality issues  all company personnel can effectively escalate product quality and QMS issues to the appropriate manager in a timely manner.

This may include the use of the corrective and preventative action process (Procedure : Corrective and Preventative Action).

Document is current only if front page has “Controlled copy” stamped in red ink

Page 6 of 8

<Company Name>

Training, Awareness and Competency Document ID: QP601

Revision No.: 01

Document Information Revision History Revision

Modified by

Description of Change

01

Complete the above fields for each revision of this document. Ensure that there is sufficient description of changes so that the change history of this document can be followed.

Additional columns can be added to include document/change tracking numbers generated by your company’s systems if required (eg. change control).

Associated forms and procedures Doc. No.

Document Title

FP601-1

Competency Requirements Matrix

FP601-3

Individual Training Record

QP403

Control of Records

QP501

Management Review Corrective and Preventative Action

List all controlled procedural documents referenced in this document (for example, policies, procedures, forms, lists, work/operator instructions Associated records Doc. No.

Document Title Training effectiveness evaluation records: training evaluation records, periodic employee evaluation reports, correlation studies between training and performance and other such records and reports.

Employee education, experience and competence records: individual employee’s records demonstrating their education and experience prior to them commencing employment, commencing a new task or taking on a new responsibility.

Competency Requirements Matrix: a table of departmental competency requirements (education, training, experience, etc.) of personnel against tasks affecting product quality.

Personnel Competence Matrix: a table of relevant employees cross-referenced against jobs and positions in a department, documenting which person is qualified to perform which job.

Employee training records: rosters, lists, certificates, diplomas, etc. evidencing that an employee has completed a particular training program. This record is established by the organisations or individuals providing the training.

Employee awareness participation records: rosters, lists, certificates, diplomas, etc. evidencing that an employee has viewed a video or presentation, attended a meeting or otherwise participated in an employee awareness program.

Document is current only if front page has “Controlled copy” stamped in red ink

Page 7 of 8

<Company Name>

Training, Awareness and Competency Document ID: QP601

Revision No.: 01

List all other referenced records in this document. For example, regulatory documents, inhouse controlled documents (such as batch record forms, reports, methods, protocols), compliance standards etc.

DOCUMENT END Sample styles follow. Delete all text to the end of the document, including this comment, prior to publishing.

5.

Heading 1 Normal

5.1. Heading 2 Subtle emphasis 5.1.1. Heading 3 HEADING 4  1.

Bullet 1 Bullet 2 Numbered step 1 (1, 2, 3 etc) a) Number step 2 (a, b, c etc)

Table heading left Table text left

Document is current only if front page has “Controlled copy” stamped in red ink

Table heading centre Table text centre

Page 8 of 8

Example form template

Just like the Procedure templates, the Form templates contain all the content that is likely to be common between companies. You modify it to suit your situation.

<Company Name> Prepared by: ....…................................. …../…...../.....

Document ID: FP709-2

Verified by: ....…................................... …../......../.....

Revision No.: 01

Authorised by: ..................................... ...../......../.....

Date of issue:

Cleaning Regimes for Product Manufacture Checklist

Regime 1. Suitable for: Equipment 1 Step

Description of action required

1

Acetone rinse

2

Hot water spray out

3

Acetone boilout

4

Nitrogen flush until dry

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Date

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Date

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Date

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Regime 2. Suitable for: Equipment 2 Step

Description of actions required

1

Methanol rinse

2

Hot water spray out

3

Methanol boilout

4

Nitrogen flush until dry

Regime 3. Suitable for: Equipment 3 Step

Description of actions required

1

Acetone rinse and /or boilout

2

Nitrogen flush until dry

Regime 4. Suitable for: Equipment 4 Step

description of actions required

1

Methanol rinse and/or boilout

2

Nitrogen flush until dry

Regime 5. Suitable for: Area 1 Step

description of actions required

1

Wash floor with antiseptic A and leave to dry

2

Wash down work surfaces with 70% alcohol

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<Company Name>

Document ID: FP709-2

Cleaning Regimes for Product Manufacture Checklist

Revision No.: 01

Document Information Revision History Revision

Modified by

Description of Change

01

Complete the above fields for each revision of this document. Ensure that there is sufficient description of changes so that the change history of this document can be followed.

Additional columns can be added to include document/change tracking numbers generated by your company’s systems if required (eg. change control).

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