Analysis on the integration of generic consistency evaluation and total quality management
10.3969/j.issn.1674-2982.2017.08.008
- VernacularTitle:仿制药一致性评价与全面质量管理一体化的解析
- Author:
Shuang DU
1
;
Yi LIANG
Author Information
1. 中国药科大学国际医药商学院 江苏南京211198
- Keywords:
Generic drugs;
Consistency evaluation;
Process quality;
Total quality management system;
Fingerprint;
Integration
- From:
Chinese Journal of Health Policy
2017;10(8):40-43
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To combine the consistency evaluation system with the total quality management,and put forward some suggestions for improving the quality of generic drugs in China.Methods:Based on the analysis of the quality of Chinese generic drugs,combined with the concept of modem process quality control,a comprehensive analysis was made on the defects of the consistency evaluation system.Results:The consistency evaluation was found to be very important for the evaluation of the results,but it is not comprehensive as the recognition is not high,and hence there are some risks in itself.As per the findings of this study,,the quality of generic drugs cannot be effectively controlled and improved at two essential points,source and the process only through the consistency evaluation.Conclusions:A good process quality management is the basis of consistency evaluation,which can compensate for the deficiency of the evaluation of the results,and reduce the risk of high input and low quality output.Therefore,it is suggested that the assessment and the total quality management standardization should be integrated and accelerated,and integrate the concept of fingerprint into the quality management system to effectively promote the quality level of Chinese generic drugs.
