辽宁省原料药生产企业新版GMP认证检查缺陷分析与对策

Analysis and Countermeasures on the Certification Inspection Defects of the New Version of GMP for Active Pharmaceutical Ingredient Manufacturers from Liaoning Province

目的:为原料药生产企业实施《药品生产质量管理规范(2010年修订)》(简称新版GMP)和提高生产管理水平提供参考。方法:采用回顾性方法,对2011年3月至2013年12月辽宁省12家原料药生产企业在新版GMP认证检查中的缺陷项目进行统计分析。结果与结论:12家企业共发现有161个缺陷项目,其中质量控制与质量保证、文件管理、物料与产品部分存在的缺陷项目最多,分别有36、31、18个,占总缺陷项目数量的比例为22.36%、19.25%、11.18%。主要体现在质量控制实验室管理不规范;文件控制缺乏有效性和缺少重要的控制数据或记录;原辅料管理、不合格中间产品和原料药处理不符合要求等方面。建议各生产企业应深入理解新版GMP内容,全面贯彻质量风险管理和生产全过程管理的理念;加强硬件系统的改造,推进新版GMP的实施;重视软件系统的建设,建立强有力的质量管理体系;提高培训的针对性和有效性,以最大限度地降低药品生产过程中的风险,提高原料药生产管理水平。

OBJECTIVE： To provide reference for active pharmaceutical ingredient （API） manufacturers to implement the Good Manufacturing Practice （2010 revision）（hereinafter referred to as the new version of GMP） and to improve the level of production management. METHODS： By retrospective analysis, the defective items of 12 API manufacturers in the new version of GMP certification inspection from Liaoning province during the period of Mar. 2011-Dec. 2013 were analyzed statistically. RESULTS ＆ CONCLUSIONS： A total of 161 defects have been found in 12 companies, and most of them were quality control and quality guarantee, document management, materials and production, which were 36, 31 and 18 items, and accounted for 22.36%, 19.25 % and 11.18%. The main issues reflected that the management of the quality control laboratory was not standardized; document control was lack of effectiveness and important control data or record; raw material management, the disposal of unqualified immediate product and API were not up to the standard, etc. Enterprises should deeply understand the new version of GMP, fully implement the concepts of quality risk management and production process management, strengthen the construction of hardware systems, and promote the implementation of GMP; pay attention to the construction of software system, establish forceful quality management system; improve the relevance and effectiveness of training, so as to minimize the risk of drug manufacturing process to the utmost and improve the production and management of raw material.