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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 routine operation of the laboratory of aseptic laboratories and the current practical problems, and to promote the pharmaceutical enterprises to strengthen quality control, improve quality inspection, reduce the risk of contaminated products on the market and ensure drug safety. Methods A total of 95 sterility testing laboratories in aseptic pharmaceutical companies were investigated in 8 provincial-level drug certification institutes including Beijing. RESULTS AND CONCLUSION Most enterprises can perform sterility testing on sterile pharmaceuticals according to GMP requirements and relevant laws and regulations. Some enterprises have professional knowledge and operation skills of personnel, administration of strains and culture media, passaging of bacteria, retesting of aseptic tests , Positive control test, confirmation of facility and equipment, and aseptic inspection of environmental monitoring.