Quality Management Systems in Pharma

7/27/2019 Quality Management Systems in Pharma

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Quality Management Systems



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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.



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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



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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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The QMS should cascade in the following manner.

Quality Statement

Quality Policy

Quality Manual

SOP’s

Form’s/ logbooks/ Test sheets



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Forms

Log Books

Test Sheets

Quality Pyramid

Quality Statement

Quality Policy

Quality Manual

SOP’s

ManufacturingInstructions



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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.



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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 arrangementsfor maintaining the quality system.



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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.



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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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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



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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



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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



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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



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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 Policy4.22 QM 4- 022 Continuous Quality Improvements

4.23 QM 4- 023 Validation Programmes Policy

4.24 QM 4- 024 Occupational Safety and HealthProgrammes Policy

5.0 QM 005-01 GLOSSARY



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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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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,



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MD

QA Production Admin Engineering



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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



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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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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 SystemsQM 3 – 003 Equipment

All major pieces of equipment used in the GMP manufactureof 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 rawmaterials, 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.



Documents

Quality Management Systems in Pharma