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21 CFR and ICH Parts:
Part 610 - General Biological Products Standards
Guideline for the Monitoring of Clinical Investigations
Canadian Medical Device Regulations - Last Amended on February 22
the design
EU GMPs with Annex 11, 15, 16, 18, 19 21 CFR and ICH Parts: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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