Application of six sigma quality improvement model in the laboratory research of generic drugs
10.12206/j.issn.1006-0111.201912161
- VernacularTitle:六西格玛质量改善模型在仿制药小试研究过程中的应用
- Author:
Na ZHOU
1
;
Qingping ZHOU
1
;
Yi LIANG
1
Author Information
1. School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing 211198, China.
- Keywords:
DMAIC model;
generic drugs;
laboratory research
- From:
Journal of Pharmaceutical Practice
2020;38(5):476-480
- CountryChina
- Language:Chinese
-
Abstract:
Objective To improve laboratory research of generic drugs in Chinese pharmaceutical enterprises, avoid the defects in the research process, and explore the feasibility of six sigma management (DMAIC) as improvement model in the process of generic drugs laboratory research. Methods The effectiveness of DMAIC implementation was evaluated through the literature search and case study of a generic API’s process with the DMAIC model. Results The DMAIC model was successfully applied in this case. The model made laboratory research more reasonable, helped R&D personnel to pinpoint key quality attributes and process parameters, etc., ensured the authenticity and completeness of experimental data, and provided valuable data for subsequent industrial production as well as meeting registration requirements. Conclusion DMAIC model can solve the problems, such as poor overall arrangement, poor connection with production, and irregular management. It embodied the idea of Quality by Design (QbD) and can be used as good reference for domestic laboratory research of generic drugs.
