Risk Analysis on the Collinear Production of Solid Preparations Based on Failure Mode and Effects Analysis as the Quality Risk Management Tools
- VernacularTitle:基于质量风险管理工具失效模式与影响分析法的固体制剂共线生产风险控制研究
- Author:
Jie SU
;
Yi LIANG
- Keywords:
Failure mode effects analysis;
Solid preparation;
Collinear production;
Risk management
- From:
China Pharmacist
2017;20(6):1117-1119
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To analyze and estimate the risks of failure modes in a pharmaceutical Co.Ltd.in Nanjing producing solid preparations by collinear production, and come up with measurements to improve the quality level accordingly.Methods: The quality risk level evaluation table for the failure modes in the various steps of collinear production was obtained through the failure mode and effects analysis (FMEA).The risk control measurements were put forward in order to control and improve different failure modes with various unacceptable risk levels.Results: The risks of solid preparations by collinear production were greatly reduced through FMEA.Conclusion: The FMEA method is an effective way to improve the quality level of collinear products.Meanwhile, there are limitations of FMEA, and other risk management methods should be combined to control the overall risk of drug production.Moreover, the failure modes at the same risk level with different properties should be analyzed and controlled accordingly.The above methods can improve the risk management level of a company and reduce the risks of cross-contamination, mistakes and air-transferring in order to enhance the efficiency of quality management system and produce safe and effective drugs.
