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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, SOP’s 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
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 Management Systems
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 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 arrangementsfor 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
company’s 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 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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Quality Management Systems
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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Quality Management Systems
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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Quality Management Systems
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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Quality Management Systems
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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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 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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Quality Management Systems
MD
QA Production Admin Engineering
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Quality Management Systems
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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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 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.
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