VarSeq 2.6.0: Advancing Pharmacogenomics and Genomic Analysis
Quality management - WHO GMP training
1. Module 2 | Slide 1 of 27 2012
Quality Management
Basic Principles of GMP
Section 1 and 2
2. Module 2 | Slide 2 of 27 2012
Quality Management
Objectives
To understand key issues in quality assurance/good manufacturing
practices/quality control.
To understand specific requirements on quality management and
quality assurance including:
Organization
Procedures, processes and resources.
To develop actions to resolve your current problems.
3. Module 2 | Slide 3 of 27 2012
Section 1 and 2
Quality Management
Quality relationships
Quality Management
Quality Assurance
GMP
Production and Quality Control
4. Module 2 | Slide 4 of 27 2012
Quality Management
Philosophy and essential elements
What is Quality Management?
The aspect of management function that determines and
implements the “quality policy”
The overall intention and direction regarding quality, as formally
expressed and authorized by top management
5. Module 2 | Slide 5 of 27 2012
Quality Management
Quality Management
The basic elements are:
An appropriate infrastructure or “quality system”
encompassing the organization structure, procedures,
processes and resources
The systematic actions necessary to ensure adequate
confidence that a product (or service) will satisfy given
requirements for “Quality”
The totality of these actions is termed “Quality
Assurance”
6. Module 2 | Slide 6 of 27 2012
Quality Management
Quality Management
Quality assurance is a management tool
In contractual situations, it also serves to generate confidence in
a supplier
QA, GMP and Quality Control are interrelated aspects of Quality
Management
They are described on the following slides in order to
emphasize their relationship and their fundamental
importance to the production and control of pharmaceutical
products
7. Module 2 | Slide 7 of 27 2012
1.1
Quality Management
Principles of Quality Assurance (QA)
Wide-ranging concept
covers all matters that individually or collectively
influence the quality of a product
Totality of the arrangements
to ensure that the drug is of the right quality for the
intended use
Quality Assurance incorporates GMP
also product design and development
8. Module 2 | Slide 8 of 27 2012
1.2
Quality Management
QA System should ensure that:
Products are designed and developed in accordance with
GLP, GCP, and GMP
Production and control operations are clearly specified in
SOPs
Managerial responsibilities are clearly specified in job
descriptions
Systems ensure that the correct starting and packaging
materials are used
9. Module 2 | Slide 9 of 27 2012
1.2
Quality Management
QA System should ensure:
Starting materials, intermediate products, bulk products are
controlled
In-process controls, calibrations, and validations are carried out
Finished products are correctly processed and checked
Products are not sold or supplied before release by authorized
persons
Systems ensure that products are appropriately stored and
distributed
10. Module 2 | Slide 10 of 27 2012
1.2
Quality Management
QA System should ensure:
Self-inspection and/or quality audits are done regularly
Deviations are reported, investigated and recorded
Changes are controlled
Systems are followed to verify the consistency of processes and
ensuring continuous improvement
Quality Risk Management is implemented
11. Module 2 | Slide 11 of 27 2012
1.3
Quality Management
Quality Assurance
Products must:
– safety, quality and efficacy requirements - fit for their intended use
– comply with the requirements of the marketing authorization
Senior management is responsible - and all staff must be
committed to achieve this.
Relies on a comprehensively designed, documented, correctly
implemented system of QA incorporating GMP and QC.
Relies on competent personnel, suitable and sufficient premises,
equipment and facilities.
12. Module 2 | Slide 12 of 27 2012
1.4 – 1.5
Quality Management
Quality Assurance
Manufacturers should manage quality risks. Quality Risk
Management (QRM) is a systematic process for:
– assessment, control, communication and review of risks to the
quality of the medicinal product.
QRM:
– can be applied both proactively and retrospectively
– Should be based on scientific knowledge and experience with
the process
– Should be linked to the protection of the patient
13. Module 2 | Slide 13 of 27 2012
Quality Risk Management
(ICH Q9)
Advanced training workshop for GMP inspectors
Nairobi , 9-12 May, 2011
14. Module 2 | Slide 14 of 27 2012
1.3
Quality Management
Quality Assurance
Quality Risk Management follows a cycle of assessment, control,
communication and review.
An appropriate tool should be used in risk assessment, such as:
– Fault Tree Analysis (FTA)
– Hazard and Operational Studies (HAZOP)
– Failure Mode and Effect Analysis (FMEA)
– Hazard Analysis and Criticality Analysis (HACCP)
– Failure Mode, Effect, and Criticality Analysis (FMECA)
15. Module 2 | Slide 15 of 27 2012
Quality Management
Failure Mode Effect Analysis
• Breakdown in manageable steps
• Process and product understanding needed
• Evaluate failure mode and effect on outcome
• Eliminate, contain, reduce, control
• (Identify mode, cause, effect)
16. Module 2 | Slide 16 of 27 2012
1.6
Quality Management
Quality Assurance
Product quality review (PQR)
Regular, periodic or rolling quality reviews of all medicinal
products
Normally annually
Objective:
– Verifying the consistency of the existing process
– appropriateness of current specifications for both starting materials and
finished product
– highlight any trends
– identify product and process improvements.
17. Module 2 | Slide 17 of 27 2012
1.6
Quality Management
Quality Assurance
PQR should include at least a review of:
– starting materials and packaging materials (especially from
new sources)
– critical in-process controls and finished product results
– all batch failures and their investigation
– deviations or non-conformances (and investigations and
CAPAs)
– all changes made to the processes or analytical methods
– dossier variations submitted, granted or refused
– results of the stability monitoring programme and any adverse
trends
18. Module 2 | Slide 18 of 27 2012
1.6
Quality Management
Quality Assurance
PQR should include (cont).:
– quality-related returns, complaints and recalls and the
investigations
– adequacy of previous corrective actions on product process or
equipment
– Post marketing commitments
– qualification status of relevant equipment and utilities
– technical agreements
19. Module 2 | Slide 19 of 27 2012
1.6
Quality Management
Quality Assurance
Results should be reviewed- assessment should be made
whether CAPA or revalidation should be undertaken
CAPA completed in a timely and effective manner – verified
Product types can be grouped
Agreements in case of contracted parties
PQR in a timely manner and verified for accuracy
20. Module 2 | Slide 20 of 27 2012
Quality Management
Quality Assurance
When inspecting PQR, also verify:
Correctness of data transferred
Trending of results
Calculations such as process capability index (CpK) - where
appropriate
Accuracy in terms of APIs reflected, approved suppliers used,
number of batches, variations, changes, complaints etc.
CAPAs and conclusion
21. Module 2 | Slide 21 of 27 2012
2.1
Quality Management
Good Manufacturing Practices (GMP)
That part of QA that ensures that products are consistently
produced and controlled
Quality standards
Marketing authorization
Aim: Diminishing risks that cannot be controlled by testing of
product
Contamination and cross-contamination
Mix-ups (confusion)
22. Module 2 | Slide 22 of 27 2012
2.1 a - c
Quality Management
Basic Requirements for GMP – I
Clearly defined and systematically reviewed processes
Qualification and validation is performed
Appropriate resources are provided:
Qualified and trained personnel
Premises, space, equipment and services
Materials, containers, labels
Procedures, storage, transport
Laboratories and in-process control
23. Module 2 | Slide 23 of 27 2012
2.1 d - j
Quality Management
Basic Requirements for GMP – I
Clear, written instructions and procedures
Trained operators
Records of actions, deviations and investigations
Records for manufacture and distribution
Proper storage and distribution
Systems for complaints and recalls
24. Module 2 | Slide 24 of 27 2012
Quality Management
Group session – I
How many GMP deficiencies can you find in the
photographs in the handout?
25. Module 2 | Slide 25 of 27 2012
Quality Management
Group session II
Imagine you are inspecting a pharmaceutical company for
compliance with GMP
Consider the situations in the next slides which may have impact
on a company’s quality management programme
Describe the action to be taken in each case
26. Module 2 | Slide 26 of 27 2012
Issues – I
Quality Management manual not established in writing
Limited human resources
Lack of qualified people
Processes not properly validated
Poor SOPs or standard batch documentation
More consideration to cost than quality
Family members in key positions of authority
Quality Management
27. Module 2 | Slide 27 of 27 2012
Issues – II
Substandard materials deliberately purchased
Technical staff not involved in purchasing
Inability to re-export substandard materials
Owner insists on selling rejects
Corruption
No commitment to training
Quality Management
Hinweis der Redaktion
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Explain with the help of the diagram, the flow of information and the process of risk assessment, risk control, risk review.