Implementation of Quality by Design in the Program of Safety Re-evaluation of TCM Injections
10.11842/wst.2013.06.034
- VernacularTitle:在中药注射剂安全性再评价工作中践行“质量源于设计”的思考
- Author:
Li LIU
;
Haibin QU
- Publication Type:Journal Article
- Keywords:
TCM injection;
safety re-evaluation;
quality by design;
critical quality attributes;
design space
- From:
World Science and Technology-Modernization of Traditional Chinese Medicine
2013;(6):1433-1436
- CountryChina
- Language:Chinese
-
Abstract:
It has been widely accepted in modern pharmaceutical industry that quality cannot be tested into products , instead quality should be built-in by design . However , the implementation of Quality by Design ( QbD ) in development , manufacture and supervision of traditional Chinese medicine ( TCM ) still remains to be a challenge . The program of safety re-evaluation of TCM injections provides an opportunity to practice QbD approach in TCM industry . This paper discussed some potential ways that improve the quality of TCM injec-tions base on QbD related tools , including identification of critical quality attributes , critical process parameters and critical material attributes, development of design space and control strategy.
