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Table Of Contents

Introduction
General considerations
Quality management in the drug industry
The contract giver
The contract accepter
Items for self-inspection
Self-inspection team
Frequency of self-inspection
Self-inspection report
Suppliers’ audits and approval
11.Personal hygiene
12.Premises
General
Ancillary areas
Storage areas
Weighing areas
Production areas
Quality control areas
13.Equipment
14.Materials
Starting materials
Packaging materials
Intermediate and bulk products
Finished products
Rejected, recovered, reprocessed and reworked materials
Recalled products
Returned goods
Reagents and culture media
Reference standards
Waste materials
Miscellaneous
15.Documentation
Documents required
16.Good practices in production
Processing operations
Packaging operations
17.Good practices in quality control
Test requirements
Batch record review
Stability studies
References
Water for pharmaceutical use1
WHO good manufacturing practices: starting materials
Active pharmaceutical ingredients (bulk drug substances)1,2
Pharmaceutical excipients1
Sterile pharmaceutical products1
Biological products1
Radiopharmaceutical products1
Inspection
Pre-approval inspections1
Inspection of pharmaceutical manufacturers1
Inspection of drug distribution channels1
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Good Manufacturing Practices and Inspection (Quality Assurance of Pharmaceuticals)

Good Manufacturing Practices and Inspection (Quality Assurance of Pharmaceuticals)

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Published by uumang

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Published by: uumang on Sep 10, 2010
Copyright:Attribution Non-commercial

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10/31/2011

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