Regulations on Good Manufacturing Practice
Request Regulations on Good Manufacturing Practice
  • Local Title:药品生产质量管理规范
  • Country/Region:Chinese Mainland
  • Competent Authority: Former Ministry of Health
  • Type:Regulation
  • Status:In force
  • Release Date:2011-01-17
  • Implementation Date:2011-03-01
Document
Language Source Title Access
ZH Official 药品生产质量管理规范 Download
Summary

The Regulations on Good Manufacturing Practice was issued on Jan.17, 2011. It aims to standardize the quality control of drug production, which includes:

1. General Provisions

2. Quality Control

3. Organization and Personnel

4. Plant and Facilities

5. Equipments

6. Materials and Products

7. Confirmation and Verification

8. File Management

9. Production Management

10. Quality Control and Quality Assurance

11. Commissioned Production and Inspection

12. Product Shipping and Recall

13. Self-checking

14. Supplementary Provisions