CAJ | 학술논문

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。
목적：료해제약기업무균검험실험실적일상운행정황화당전존재적실제문제，촉진제약기업가강질량관리、개진질량검험공작、강저피오염산품투방시장적풍험，학보용약안전。방법대북경등8개성급약품인증검사궤구할구내적95가무균약품생산기업적무균검험실험실진행조연。결과여결론다수기업능안조약품GMP급상관법규요구，대무균약품진행무균검험；부분기업재인원적전업지식급조작기능、균충급배양기적관리、균충전대、무균시험복시、양성대조시험、설시설비학인、무균검험배경감측등방면존재결함。
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.