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Quality Management Systems in Pharma

The document discusses quality management systems for pharmaceutical companies. It provides definitions for key terms like quality system and quality manual. It describes the primary purpose of a quality system as ensuring adequate quality standards are maintained. It recommends that the quality management system cascade from quality statement to quality policy, quality manual, standard operating procedures, forms, logbooks and test sheets. It provides an example table of contents and descriptions for sections that would be included in a quality manual.

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Shivam Dave
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812 views

Quality Management Systems in Pharma

The document discusses quality management systems for pharmaceutical companies. It provides definitions for key terms like quality system and quality manual. It describes the primary purpose of a quality system as ensuring adequate quality standards are maintained. It recommends that the quality management system cascade from quality statement to quality policy, quality manual, standard operating procedures, forms, logbooks and test sheets. It provides an example table of contents and descriptions for sections that would be included in a quality manual.

Uploaded by

Shivam Dave
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Quality Management Systems

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Quality Management Systems


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.

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Quality Management Systems


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, SOPs etc

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Quality Management Systems


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.

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Quality Management Systems


The QMS should cascade in the following manner. Quality Statement Quality Policy Quality Manual SOPs Forms/ logbooks/ Test sheets

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Quality Statement Quality Policy Quality Manual SOPs Manufacturing Instructions

Forms Log Books Test Sheets Quality Pyramid


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Quality Management Systems


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

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Quality Management Systems


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.

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Quality Management Systems


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 companys procedures.

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Quality Management Systems


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

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Quality Management Systems


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

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Quality Management Systems


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

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Quality Management Systems


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

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Quality Management Systems


4.10 4.11 4.12 4.13 4.14 4.15 4.16 QM 4-010 Inspection and Test Status Policy QM 4-011 Control of Non-Conforming Product Policy QM 4-012 Corrective and Preventive Action Systems Policy QM 4-013 Handling and Storage of Materials and Products Policy QM 4-014 Control of Quality Records Policy QM 4-015 Internal Quality Audits Policy QM 4-016 Training Programmes Policy
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4.18 4.19 4.20 4.21 4.22 4.23 4.24 5.0 QM 4-018 Statistical Techniques Policy QM 4-019 Computer Systems Management Policy QM 4-020 Facility Control Policy QM 4-021 Management of Production Equipment and Critical Process Utilities Policy QM 4- 022 Continuous Quality Improvements QM 4- 023 Validation Programmes Policy QM 4- 024 Occupational Safety and Health Programmes Policy QM 005-01 GLOSSARY
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Quality Management Systems


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.

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Quality Management Systems


QM 002 Organisation This includes a description of the companys activities i.e. its 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,

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Quality Management Systems

MD QA Production Admin Engineering

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Quality Management Systems


The organogram should list out positions but not the persons 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

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Quality Management Systems


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.

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Quality Management Systems


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.

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Quality Management Systems


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.
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