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Part 314 - Applications for FDA Approval to Market a New Drug
the design
Includes ICH Q7 (Annex 18/Part II)
US FDA Title 21 CFR Parts:
Part 610 - General Biological Products Standards
EU GMPs with Annex 11, 15, 16, 18, 19 Part 314 - Applications forThe 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
