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目的:为北京市药品监管部门制定和完善针对性监管措施和北京市药品生产企业更加规范地实施《药品生产质量管理规范(2010年修订)》(简称新版GMP)提供技术依据。方法:对北京市2015年1月至2016年6月认证的108家药品生产企业缺陷项目通过频数分布法进行统计分析。结果:108家药品生产企业共发现1 063项缺陷项目,其中质量控制与质量保证、文件管理、设备部分存在的缺陷项目最多,占总缺陷项目数量的比例分别为24.37%,19.85%,15.99%,主要体现在质量控制实验室管理不规范;文件内容不准确、不清晰、不完整;设备和仪器状态标识不符合要求等。结论:建议药品监管部门通过对缺陷项目的关注,制定针对性的监管措施,加大监管力度;药品生产企业应针对共性缺陷项目制定针对性解决方案,并以共性缺陷项目作为自检工具,加强内部管理,制定针对性培训计划和培训方案,加大培训力度,推进新版GMP的实施。
OBJECTIVE: To provide technical basis for Beijing drug regulatory authorities to formulate and perfect pertinent regulatory measures and to further standardize the implementation of the “Good Manufacturing Practices for Pharmaceutical Production (2010 Revision)” (the new version of GMP) by pharmaceutical manufacturers in Beijing. Methods: A total of 108 pharmaceutical manufacturing enterprises in Beijing from January 2015 to June 2016 were identified by frequency distribution. Results: A total of 1 063 items of defects were found in 108 drug manufacturers. Among them, there were the most defective items in quality control and quality assurance, document management and equipment, accounting for 24.37%, 19.85% and 15.99% respectively of the total number of defective items. , Mainly reflected in the quality control laboratory management is not standardized; the contents of the documents are not accurate, unclear and incomplete; the status of equipment and instruments does not meet the requirements and so on. Conclusion: It is suggested that drug regulatory authorities should focus on the defective items to formulate targeted regulatory measures and strengthen supervision; pharmaceutical manufacturers should develop targeted solutions to common defects and common defects as a self-check tool to strengthen Internal management, develop targeted training programs and training programs, increase training and promote the implementation of the new version of GMP.