Minitab软件在药品生产质量控制中的应用

The Application of Minitab Software in the Quality Control of Pharmaceutical Production

目的:探讨药品生产过程的质量控制方法。方法:以甲硝唑芬布芬胶囊为例,收集胶囊充填时的装量数据,运用Minitab软件制作质量控制图,监控制造过程,评价过程能力。结果:及时发现了看似稳定的生产过程中的异常,装量均在内控标准范围内,但已呈现不良趋势,且过程能力指数值较低(CPK=0.78);进行在线改进后,过程标准差显著降低(P<0.05),过程能力值增加(CPK=0.90);持续改进后,过程能力指数明显提高(CPK=1.12)。结论:基于Minitab的质量控制图及过程能力分析是提高药品生产稳定性、保证药品质量的较好方法。

Objective：To investigate the quality control methods in the pharmaceutical production process. Methods： Taking metronidazole fenbufen capsules as an example, the filling quantity data was collecd, the quality control chart made by the Minitab software was used to monitor the manufacturing process, evaluate the process capability and analyze the process stability. Results： The abnormality in the process which seemed stable was found timely. The filling quantity was in .the range of the internal control standards, but adverse trend had presented with a low value of process capability index （CPK = 0.78 ）. After the online improvement was made, the process standard deviation significantly reduced （P 〈 0.05 ） and the process capability value increased （CPK = 0.90）. After the further improvement, process capability index obviously increased （CPK = 1.12）. Conclusion： The application of Minitab software in the analysis of quality control chart and the process capability proved as a suitable method to improve the stability of the pharmaceutical production and ensure the drug quality.