T/JXYXH 0001-2022
Guide to annual report on product quality review for drug manufacturing enterprise (English Version)
- Standard No.
- T/JXYXH 0001-2022
- Language
- Chinese, Available in English version
- Release Date
- 2022
- Published By
- Group Standards of the People's Republic of China
- Latest
- T/JXYXH 0001-2022
- Scope
- Through the formulation of the "Guidelines for Product Quality Review and Analysis of Annual Reports" standards, companies can conduct product quality review and analysis of all drugs produced by variety to confirm the stability of their processes, as well as the applicability of current quality standards for raw materials, excipients, and finished products, etc. , timely discover adverse trends, determine the direction of product and process improvement, and conduct self-inspections on the effectiveness of product quality analysis to comprehensively control product quality to be stable, safe and effective, and provide scientific basis for continuous improvement of product quality.
T/JXYXH 0001-2022 history
- 2022 T/JXYXH 0001-2022 Guide to annual report on product quality review for drug manufacturing enterprise
