我国药品生产过程中记录的计算机化研究.docVIP

摘要 研究背景：研发生产记录计算机化系统在制药界的使用日趋广泛。由于业界对计算机化系统的验证缺乏理解，尽管药监机构不要求企业在药品生产过程中使用计算机化记录，但是如果使用计算机化记录作为生产管理的一种手段，就必须符合GMP的相关规定，因此形成了企业希望使用计算机化记录但是又不敢使用的尴尬局面。 研究目的：通过对美国食品药品管理局Part 11法规以及我国新版GMP的剖析，探索采用记录计算机化存在的难度以及法规局限性和技术限制性，建立计算机化系统验证Part 11合规性分析方法，为企业在选择先进设备和提高企业信息化管理提供参考。 研究方法：比较中美对计算机化记录管理的要求差异，归纳药企在记录管理上存在的问题，分析药品生产过程中使用计算机化记录的益处，调查计算机化记录在我国药企中的使用现状和动因，归纳性地建立Part 11相关性评估和符合性验证的具体方法和步骤。 研究结果和结论：企业通过提高自身的管理水平和工艺稳定性，培养专业技术团队，并采用符合自身实际需要的系统或项目实施策略，可通过使用计算机化系统来提高管理水平和竞争力。 关键词：风险评估；21 CFR Part 11；计算机化记录；计算机化系统 Study onComputerized Records in Chinese Pharmaceutical Society Abstract Background: Computerizedsystemsarebecoming morewidelyusedin the development and manufacturing in pharmaceuticalindustry. Although electronic record is not required to be used by the regulatory agencies, the electronic record must meet GMP requirements if it has been used as a method for the manufacturing management; however, due to the lack of knowledge of the validation of the computerized system, the awkward situation that the manufacturers want to use computer system but dare not to use has been formed. Objective: Based on the analysis of the Part 11, CFR 21 in US FDA and the new version of GMP in China, the difficulties and limitations of the computerized system both from legal perspectives and technological perspectives were explored to establish the compliance analysis methods according to the Part 11 to provide the references for the manufacturers to select advanced equipment and improve the computerized management in the manufacturers. Methods: The requirement differences in the electronic records in China and US are compared, and the existing problems in electronic records in the pharmaceutical manufacturers are summed up, the advantages of the electronic records in the manufacturing process of the pharmaceutical products are analyzed, the current situation and the incentives for the using of electronic records in the domestic pharmaceutical manufacturers are surveyed, an