Implementation of Quality by Design in the Program of Safety Re-evaluation of TCM Injections / 世界科学技术-中医药现代化
World Science and Technology-Modernization of Traditional Chinese Medicine
;
(12): 1433-1436, 2013.
Article
in Chinese
| WPRIM
| ID: wpr-441629
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Type of study:
Evaluation studies
/
Systematic review of observational studies
Language:
Chinese
Journal:
World Science and Technology-Modernization of Traditional Chinese Medicine
Year:
2013
Type:
Article
Similar
MEDLINE
...
LILACS
LIS