Validation of Analytical Procedures in European and American Drug Registration Files
- VernacularTitle:欧美原料药进口注册文件中的分析方法验证
- Author:
Sheng WEI
- Publication Type:Journal Article
- Keywords:
Europe and America;
Crude drug;
Registration;
Analytical procedures;
Validation
- From:
China Pharmacy
1991;0(04):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To promote the international drug registration for Chinese pharmaceutical enterprises.METHODS:Based on the requirements on drug registration in Europe and the USA,we expounded the validation on analytical procedures and put forward some concrete methods.RESULT & CONCLUSION:Validation of analytical procedures plays an important role both in quality control and international drug registrations,to which Chinese enterprises should given great attention.
