Pharmaceutical Quality System “PQS” in terms of ISO system and GMP guideline
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- Pharmaceutical Quality System “PQS” in terms of ISO system and GMP guideline
Programs
Start Date
January 30, 2025
January 30, 2025
Course Visits: 3,054
Duration
20 Hours
20 Hours
Course Content:
- a) The road to a Pharmaceutical Quality System Principles of process validation
- b) Introduction to the PQS
- General requirements
- Documentation
- c) Main elements of a PQS
- Management responsibility
- Resource management
- Manufacturing operations
- Evaluation activities:-
- Deviation investigation
- Product Quality Review (Annual Product Review)
- Change management
- Corrective and Preventive Actions (CAPA)
- Data analysis
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- d) ICH Q10
- e) Structure of a PQS quality manual – example
- f) Correlation between GMP requirements (WHO) and ISO 9001
