2021年至2022年贵州省药品生产企业常规检查情况分析

Analysis of Routine Inspection of Drug Manufacturing Enterprises in Guizhou Province from 2021 to 2022

目的提高贵州省药品生产企业严格执行《药品生产质量管理规范(2010版)》(简称GMP)的能力水平。方法总结2021年至2022年贵州省内107家次药品生产企业进行常规检查时发现的缺陷项目,分析其在执行GMP过程中存在的问题,从企业和省级药品监督管理部门的角度分别提出相应的对策或建议。结果药品生产企业常规检查共发现缺陷889项,其中严重缺陷7条,主要缺陷26条,一般缺陷857条,平均9.1条/家。问题主要集中在设备、质量控制与质量保证、文件管理等章节。结论药品生产企业应持续强化质量管理水平,进一步落实主体责任;监管部门应加强职业化专业化药品检查员队伍建设,进一步提升科学监管的能力水平。

Objective To improve the implementation level of the Good Manufacture Practice(GMP,2010 version)of drug manufacturers in Guizhou Province.Methods The defect items founded during the routine inspections of 107 drug production enterprises were summarized in the province from 2021 to 2022,and the existung problems in the implementation of GMP were analyzed,and the corresponding countermeasures or suggestions from the perspectives of enterprises and provincial drug supervision and management departments were proposed.Results A total of 889 defects were found in the routine inspection of drug manufacturing enterprises,including 7 serious defects,26 major defects,and 857 general defects,with an average of 9.1 per enterprise.The problems mainly focused on chapters such as equipment,quality control and assurance,and document management.Conclusion Drug manufacturing enterprises should continue to strengthen the level of quality management,and further implement the main responsibility.Regulatory authorities should strengthen the construction of the professional and specialized team of drug inspectors,and further enhance the level of scientific supervision capabilities.