Approach to Depuratory Authentication of Facilities of Chinese Drugs Preparations
- VernacularTitle:对中药制剂设备清洁验证的探讨
- Author:
Yi LIANG
;
Jiangbo CAI
- Publication Type:Journal Article
- Keywords:
Chinese drugs preparations;
Depuratory authentication;
Regulations
- From:
China Pharmacy
2001;0(09):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To provide approaches and avenues for the Chinese drugs preparations manufacturers in the GMP depuratory authentication.METHODS:The features and difficulties in the GMP depuratory authentication of the Chinese drugs preparations such as the optimizing of depuratory regulations,the determination of the acceptable standards,the choice of testing methods,clarification of expiration date and re-authentication were analyzed.RESULT&CONCLUSION:The depuratory regulations of the manufacturing facilities for the Chinese drugs preparations must be optimized.
