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Pharmaceutical GMP Auditor's Checklist
Part 314 - Applications for FDA Approval to Market a New Drug
Includes ICH Q7 (Annex 18/Part II)
Added Chinese GMPs Decree 79 (English)
the design
EU GMPs with Annex 11, 15, 16, 18, 19 Pharmaceutical GMP Auditor's ChecklistThe 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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