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the design
US FDA Title 21 CFR Parts:
Guideline for the Monitoring of Clinical Investigations
Pharmaceutical GMP Auditor's Checklist
EU GMPs with Annex 11, 15, 16, 18, 19 the designThe 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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