Minitab软件在新版GMP产品质量回顾分析中应用.docVIP

Minitab软件在新版GMP产品质量回顾分析中应用 　　摘 要 目的：探讨Minitab软件在新版GMP产品质量回顾分析中的应用意义。方法：以公司某产品的灌装装量为例，收集装量检测数据，运用Minitab软件制作质量控制图，评价过程能力。结果：发现了看似稳定的灌装装量检测过程中的异常，容量法装量检测的数据虽然均在内控标准范围内，但已呈现不良趋势，且过程能力值较低（Cp=1.22，Cpk=1.15）；进行调查分析、改进后重量法装量检测的数据过程能力值增加（Cp=1.63，Cpk=1.50）；结论：基于Minitab质量控制图及过程能力分析是提高药品生产稳定性和保证药品高质量的好方法，是制药企业在实施GMP过程中进行产品质量回顾的有效工具，Minitab软件在新版GMP产品质量回顾分析中的应用是科学和有效的，分析结果可用于指导生产操作。 　　关键词 Minitab软件 过程能力指数 正态性检验 质量控制图 药品生产质量管理规范 　　中图分类号：TQ460.63 文献标识码：A 文章编号：1006-1533（2015）03-0076-05 　　ABSTRACT Objective： To investigate the application of Minitab software in the product quality reviews. Methods： Taking a product filling device in a company as an example， the device detection data were collected and quality control charts were made using Minitab software， and the process capability was evaluated and the process stability was analyzed. Results： The abnormality in the process which seemed to be stable was found. Although timely volumetric loading test data were located in the internal standard range， there had a negative trend and the process capability was lower （Cp=1.22， Cpk=1.15）. The process ability of the data based on weight loading value detection was increased after investigation， analysis and improvement （Cp=1.63， Cpk=1.50）. Conclusion： The quality control chart based on Minitab analysis and the process capacity are a good way to improve the stability of drug production and to ensure the high quality of drugs and an effective tool as well for the pharmaceutical enterprises to perform the product quality review in the process of GMP implementation. Application of Minitab software in the new version of the GMP product quality review analysis is scientific and effective， and the results of the analysis can be used to guide the production operation. 　　KEY WORDS Minitab software； process capability index； process capability index； test of normality； quality control chart； good manufacturing practice for pharmaceutical products 　　Minitab 软件与产品质量回顾 　　Minitab是一款统计技术数据处理软件，1