EU GMPs with Annex 11, 15, 16, 18, 19 Canadian Medical Device Regulations -

Canadian Medical Device Regulations - Last Amended on February 22

Part 314 - Applications for FDA Approval to Market a New Drug

the design

Includes ICH Q7 (Annex 18/Part II)

The EU GMPs includes Chapters 1-9 - EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use

EU GMPs with Annex 11, 15, 16, 18, 19 Canadian Medical Device Regulations -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