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GMP Publications - Code of Federal Regulation Handbooks by the FDA

EU GMPs with Annex 11, 15, 16, 18, 19

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978-1-935131-98-4

The EU GMPs include Chapters 1-9 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary.
Includes:
Annex 11 - Computerized Systems
Annex 15 - Qualification and Validation
Annex 16 - Qualified Person and Batch Release
Annex 18 - (ICH Q7)Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Annex 19 - Reference and Retention Samples




















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