安徽省中药注射剂生产企业监督检查情况分析与改进策略

Situation Analysis and Improvement Strategies of Supervision and Inspection of Traditional Chinese Medicine Injection Manufacturers in Anhui Province

目的促进中药注射剂质量管理水平与产品质量的提升。方法依据《药品生产质量管理规范(2010年修订)》等相关规定,安徽省药品审评查验中心2021年对安徽省6家中药注射剂生产企业进行监督检查,汇总、分析存在的问题,并有针对性地提出改进建议。结果检查结果为符合要求或基本符合要求;未发现关键处方工艺与注册申报不一致的问题;共发现缺陷70项,平均每家企业约12项,其中主要缺陷4项(5.71%)、一般缺陷66项(94.29%),无严重缺陷;缺陷主要集中于质量控制与质量保证、文件管理、附录无菌药品3个章节,分别有14项(20.00%)、12项(17.14%)、10项(14.29%);已基本开展药品不良反应监测工作。针对以上缺陷,建议企业强化风险意识,规范变更控制和偏差处理,提高文件管理水平,重视过程控制,严控物料管理和生产管理,加强药品不良反应监测,持续开展中药注射剂研究工作。结论企业应落实药品上市许可持有人安全主体责任,不断提高和完善中药注射剂的质量管理水平,加强药品不良反应监测和上市后研究,确保中药注射剂的质量。

Objective To promote the improvement of the quality management level and product quality of traditional Chinese medicine(TCM)injections.Methods According to relevant regulations such as the Good Manufacturing Practice for Pharmaceutical Products(Revised in 2010),the supervision and inspection on the situation of six TCM injection manufacturers were conducted by the Anhui Center for Drug Evaluation&Inspection in Anhui Province in 2021,the existing problems were summarized and analyzed,and the targeted improvement suggestions were proposed.Results The inspection results met the requirements or basically met the requirements.No inconsistencies were found between the key prescription process and the registration application.A total of 70 defective items were found,with an average of about 12 items per manufacturer,including four major defective items(5.71%)and 66 general defective items(94.29%),without serious defective items.The defective items were mainly concentrated in three chapters:quality control and assurance(14 items,20.00%),documentation management(12 items,17.14%),and Annex 1:sterile medicinal products(10 items,14.29%),respectively.All manufacturers have basically carried out adverse drug reaction monitoring.In response to the above 70 defective items,it was recommended that manufacturers should strengthen risk awareness,standardize change control and deviation handling,improve documentation management level,attache importance to process control,strictly controll material management and production management,strengthen adverse drug reaction monitoring,and continue to research TCM injections.Conclusion Manufacturers should implement the main responsibility for drug safety of the marketing authorization holders,continuously improve the quality management level of TCM injections,strengthen adverse drug reaction monitoring and post-marketing research,and ensure the quality of TCM injections.