药品生产企业无菌检验实验室调研报告

A Survey on Sterility Testing Laboratories of Drug-Manufacturing Enterprises

目的了解制药企业无菌检验实验室的日常运行情况和当前存在的实际问题,促进制药企业加强质量管理、改进质量检验工作、降低被污染产品投放市场的风险,确保用药安全。方法对北京等8个省级药品认证检查机构辖区内的95家无菌药品生产企业的无菌检验实验室进行调研。结果与结论多数企业能按照药品GMP及相关法规要求,对无菌药品进行无菌检验;部分企业在人员的专业知识及操作技能、菌种及培养基的管理、菌种传代、无菌试验复试、阳性对照试验、设施设备确认、无菌检验环境监测等方面存在缺陷。

Objective To understand the daily operation status and current existing problems in sterility testing laboratories of drug manufacturing enterprises,so as to facilitate them enterprises to strengthen quality management,improve quality test,reduce the risk of launching contaminated products into the market and ensure drug safety.Methods The study was carried out on sterility testing laboratories of 9 5 sterility drug-manufacturing enterprises in Beij ing and other 7 provincial drug certification and inspection bodies.Results and Conclusion Most enterprises were capable of carrying out sterility test for sterility drugs in accordance with GMP and relevant legal requirements;some enterprises had deficiencies in professional knowledge and staff operating skills,management of bacteria and culture medium,passage of bacteria,reexamination for sterility test,positive control test,facilities and equipment confirmation as well as environmental monitoring of sterility test.