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The quality management system (QMS) is the corner stone of compliance to GMP. The QMS is made up of several documents, that when followed ensures the GMP compliance of the process, facility and company. A good QMS uses a cascade of these documents and each level references the level above. 2

DEFINITIONS Quality system: The sum of all that is necessary to implement an organisation's quality policy and meet quality objectives. It includes organisation structure, responsibilities, procedures, systems, processes and resources. Typically these features will be addressed in different kinds of documents as the quality manual and documented procedures, SOP s etc 3

The primary purpose of a quality system is to ensure that adequate quality standards are maintained. The quality system should include all activities involved in the GMP inspection process. 4

The QMS should cascade in the following manner. Quality Statement Quality Policy Quality Manual SOP s Form s/ logbooks/ Test sheets 5

Quality Statement Quality Policy Quality Manual SOP s Manufacturing Instructions Forms Log Books Test Sheets Quality Pyramid 6

Quality Statement. This is a statement by the company s senior management expressing their commitment to Quality. It is sometimes reflected in the company s vision statement. Quality Policy This is a document that describes the company s approach to Quality. It will usually include references to the standards used. 7

Quality manual The Pharmaceutical Company should prepare and maintain a quality manual covering the elements described in this document. It is for each Pharmaceutical Company to decide on the format and style of their quality manual, but it must include, or make reference to, the quality system procedures which define the activities of the Company and the arrangements for maintaining the quality system. 8

The reference used to complete it (as ISO or EN norms) must be quoted too. The following is just an example of a quality manual. You should write your quality manual to represent your company s procedures. 9

Table of Contents 1.0 QM 001 QUALITY MANUAL OVERVIEW 1.1 QM 1 001 Distribution List 1.2 QM 1 002 Table of Contents 1.3 QM 1 003 Quality Policy Statement 1.4 QM 1 004 The Quality Manual - Introduction 10

2.0 QM 002 THE ORGANISATION 3.0 QM 003 THE MANUFACTURING FACILITY 3.1 QM 3 001 Premises 3.2 QM 3 002 Contamination Control 3.3 QM 3 003 Equipment 3.4 QM 3 003 Production Support Utilities 11

4.0 QM 004 THE QUALITY SYSTEM 4.1 QM 4-001 Quality System Description 4.2 QM 4-002 Management Responsibility 4.3 QM 4-003 Change Control Policy 4.4 QM 4-004 Document Control Policy 12

4.5 QM 4-005 Purchasing and Vendor Assurance Policy 4.6 QM 4-006 Material and Product Identification and Traceability Policy 4.7 QM 4-007 Process Control Programmes Policy 4.8 QM 4-008 Inspection and Test Programmes Policy 4.9 QM 4-009 Calibration Programmes Policy 13

4.10 QM 4-010 Inspection and Test Status Policy 4.11 QM 4-011 Control of Non-Conforming Product Policy 4.12 QM 4-012 Corrective and Preventive Action Systems Policy 4.13 QM 4-013 Handling and Storage of Materials and Products Policy 4.14 QM 4-014 Control of Quality Records Policy 4.15 QM 4-015 Internal Quality Audits Policy 4.16 QM 4-016 Training Programmes Policy 14

4.18 QM 4-018 Statistical Techniques Policy 4.19 QM 4-019 Computer Systems Management Policy 4.20 QM 4-020 Facility Control Policy 4.21 QM 4-021 Management of Production Equipment and Critical Process Utilities Policy 4.22 QM 4-022 Continuous Quality Improvements 4.23 QM 4-023 Validation Programmes Policy 4.24 QM 4-024 Occupational Safety and Health Programmes Policy 5.0 QM 005-01 GLOSSARY 15

QM1-004 Quality Manual Introduction This is an overview of the Quality Manual - it assists reviewers with how the manual is set out and organised. This can be staff, customers or Drug Regulatory Agencies (DRA) The introduction will also include the reference to the quality standards used i.e. US FDA, EU or WHO etc. 16

QM 002 Organisation This includes a description of the company s activities i.e. it s primary manufacture at the site. There should be a description of relationships with any other company (if applicable) such as parent or sister companies. There should be an organogram showing the relationship between each division / group and the company structure, 17

MD QA Production Admin Engineering 18

The organogram should list out positions but not the person s name. There should a clear path of command for QA/QC to Senior Management without any interaction with the Production group. All Departments such as R&D, Admin, Regulatory, Legal should all be depicted and their relationship with the Operations group defined 19

QM 3-001 Premises A description of the facility, including address and site plan. This section should contain references to the standards used for the design - US FDA, EU, WHO, ASME etc. Include description of classified areas i.e. Grade A, B, C or D. Describe the features of the design that help prevent cross contamination or segregation of product such unilateral flow. Describe how the any crossovers are dealt with - i.e. time based or cleaning regimes. 20

QM 3 002 Contamination Control This section describes briefly how the classified areas maintain their contamination control such as using a validated HVAC system or particulate and bioburden testing within the area. This is very important for biological facilities but should be a concern in all pharma facilities. 21

QM 3 003 Equipment All major pieces of equipment used in the GMP manufacture of the product should be listed here, such as autoclaves, washers, bioreactors, chromatography systems. All major pieces of equipment used in the QC lab to test raw materials, product or in-process or environmental testing should be listed here, such as TOC, ELISA reader, Spectrophotometer. All major pieces of equipment in the Utilities should be listed here, such Purified Water Systems, WFI generator, Clean steam generator. 22