Go To Content
  • facebook
  • Google
  • Line
  • Twitter
  • Forward
  • Print

Guidance, Law & Regulations

Pharmaceutical Good Manufacturing Practice Regulations

【Update Date:2018-10-26】 unit:品質監督管理組
【Announced Date:2013-03-11】
【Amended Date:2013-07-30】
Part 1 General Provisions
Part 2 Good Manufacturing Practices for Pharmaceuticals
Chapter 1 Good Manufacturing Practices for Western Pharmaceuticals
Chapter 2 Good Manufacturing Practices for Chinese Herbal Medicines
Section 1 General Provisions
Section 2 Environmental Sanitation
Section 3 FactoryBuildings and Facilities
Section 4 Facilities
Section 5 Organization and Personnel
Section 6 Management of Raw Materials and Product Containers and Caps
Section 7 Manufacturing Process Control
Section 8 Management of Packaging and Labeling
Section 9 Storage, Shipping and Sales
Section 10 Quality Control
Section 11 Records and Reports
Section 12 Handling of Complaints and Returned Products
Section 13 Pharmaceuticals for Use in Clinical Trials
Part 3 Good Manufacturing Practices for Medical Devices
Chapter 1 General Provisions
Chapter 2 Standard Mode
Section 1 Quality Management System
Section 2 Management Responsibility
Section 3 Resource Management
Section 4 Product Realization
Section 5 Measurement, Analysis and Improvement
Chapter 3 Essential Mode
Chapter 4 Medical Devices for Use in Clinical Trials
Part 4 Supplementary Provisions