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Introduction to ICH Q7A, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
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Introduction to ICH Q7A, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
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Change Control
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Complaints and Recalls
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Chapter
Introduction
Quality Management
Personnel
Building and Facilities
Process Equipment
Documentation and Records
Material Management
Production and In- Process controls
Packaging and identification Labeling of API’s and Intermediates
Storage and Distribution
Laboratory Controls
Validation
Change Control
Rejection and Re-Use of Materials
Complaints and Recalls
Contract Manufacturers (Including Laboratories)
Agents, Brokers, Traders, Distributors , Repackers and Relabellers
Specific Guidance for API’s Manufactured by cell Culture / Fermentation
API’s for Use in Clinical Trials
Instructions for Evaluation
Evaluation Questionnaire.
10 questions
