Chinese Pharmacopoeia 2020 Edition 9205 Guideline, Microbiological Monitoring and Control in Pharmaceutical Clean Laboratories Interpretation of the Guidelines and Discussion
10.13748/j.cnki.issn1007-7693.20223288
- VernacularTitle:中国药典2020年版9205药品洁净实验室微生物监测和控制指导原则解读及探讨
- Author:
XUAN Ze
1
;
JIANG Zhijie
1
Author Information
1. Beijing Institute for Drug Control, Beijing Center for Vaccine Control, NMPA Key Laboratory for Research and Evaluation of Generic Drugs, Beijing 102206, China
- Publication Type:Journal Article
- Keywords:
Chinese Pharmacopeia;
United States Pharmacopeia;
pharmaceutical clean laboratories;
microbiological monitoring;
guidelines
- From:
Chinese Journal of Modern Applied Pharmacy
2023;40(16):2290-2294
- CountryChina
- Language:Chinese
-
Abstract:
The Chinese Pharmacopoeia 2020 edition 9205 guideline requirements for microbiological monitoring and control of pharmaceutical clean laboratories has an important value for the analysis methods, daily test operations and management processes of cleanroom-related clean parameters. By analyzing the updated comparison with the 2015 edition, comparing the relevant domestic and international standard regulations, from the detection items, details of project requirements and specific operational implementation, and the results of daily inspection work experience, the key indicators in the general rules were re-evaluated and proposed to improve the project or add new items to provide reference for the next edition of the pharmacopoeia guidelines revision.
