The Appendix to the Good Manufacturing Practice for Pharmaceutical Products (Revised in 2010) for Drugs Used in Clinical Trials was issued on May.27, 2022. It includes:
Chapter 1 Scope
Chapter 2 Principles
Chapter 3 Quality Management
Chapter 4 Personnels
Chapter 5 Plants, Facilities and Equipments
Chapter 6 Material Management
Chapter 7 Documents Management
Chapter 8 Preparation management
Chapter 9 Quality Control
Chapter 10 Permission
Chapter 11 Dispatch
Chapter 12 Complaints and Recalls
Chapter 13 Recall and Destruction
Chapter 14 Supplementary Provisions