Comparative Analysis of Test and Retest Contents between the Management of Drug Quality Sampling and Testing and the Regulation of Drug Quality Sampling and Testing
- VernacularTitle:《药品质量抽查检验管理办法》与《药品质量抽查检验管理规定》中检验和复验内容的对比分析
- Author:
Wen LIU
1
;
Jiong ZHU
1
;
Jun HU
2
;
Chong WANG
1
;
Zengyao HU
3
Author Information
1. Center of Technical Supervision，National Institutes for Food and Drug Control，Beijing 102629，China
2. Shanghai Center for Food and Drug Safety Research，Shanghai 200233，China
3. Dept. of Drug Regulation，National Medical Products Administration，Beijing 100037，China
- Publication Type:Journal Article
- Keywords:
Management of drug quality sampling and testing;
Test;
Retest;
Comparative analysis
- From:
China Pharmacy
2020;31(14):1665-1670
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE：To provide re ference for the relevant personnel of drug quality sampling and testing to understand and implement the new requirements in the Management of Drug Quality Sampling and Testing . METHODS ：The test and retest requirements were compared between the Management of Drug Quality Sampling and Testing and the Regulation of Drug Quality Sampling and Testing. The revised and newly added contents were analyzed ，and the recommendations for implementation were put forward. RESULTS & CONCLUSIONS ：Referring to drug regulation need ，related requirements of test and retest in the Management of Drug Quality Sampling and Testing were modified and supplemented on the basis of the Regulation of Drug Quality Sampling and Testing . In the requirements for test ，the requirements for test items were revised ，the requirements for test time limit were confirmed ，the requirements for test report ，original record and quality management system ，the definition of “serious risk ” and its reporting requirements were added newly. The requirements for exploratory research were put forward for test institutions， as well as new requirements for test institutions and inspectors ’behaviors. In the requirements for retest ，the materials to be submitted for retest were revised ，and the identity certificate of the manager and time limit certificate were added ；the situation of no-retest were revised ，and the treatment method were added when obviously visible foreign matters were detected ；transfer requirements for retest report were added newly. It is suggested that the relevant personnel should pay more attention to the above changes，strengthen the construction of test capacity a nd the management of tes t time and quality ，attach importance to serious quality risks ，actively carry out exploratory research ，and mind their own test behaviors ；strictly review retest materials ， pay attention to the newly revised no-test and comprehensively transfer the retest report according to the requir ements and actual situation ，conduct and implement the Management of Drug Quality Sampling and Testing actively.
