摘要
目的帮助生产企业和药品生产质量管理规范(GMP)检查员了解培养基模拟灌装试验中的关键点,改进缺陷以符合法规要求。方法分析无菌药品生产企业GMP认证现场检查发现的缺陷中涉及培养基模拟灌装试验的问题,及其产生原因。结果与结论共发现与培养基模拟灌装相关的缺陷项378条,出现频次较高的缺陷分为人员与培训、方案设计、培养基及培养条件、记录缺失、最差条件、干扰设计、偏差调查7个方面。分析其表现及对策,有助于形成培养基模拟灌装试验的关注要点与重点。
Objective To help the manufacturing enterprises and CMP inspectors understand the key points in simulated test of culture media fill and improve the defects to meet the requirements of regulations. Methods The problems and causes of defects involved in simulated test of culture media fill were found and analyzed in the CMP certification on- site inspection of aseptic drug manufacturers. Results and Conclusion Totally 378 defects related to simulated test of culture media fill were found. Higher frequency of defects were divided into seven aspects：personnel and training,program design,culture media and condition of culture,record missing,worst condition,interference design,deviation survey. The analysis of its performance and countermeasures will help to form the key points of simulated test of culture media fill.
作者
毛红
Mao Hong(Chongqing Center for Drug Evaluation and Certification,Chongqing,China 401120)
出处
《中国药业》
CAS
2018年第18期80-82,共3页
China Pharmaceuticals
关键词
无菌药品
培养基模拟灌装试验
缺陷分析
改进措施
sterile drug products
simulated test of culture media fill
defect analysis
improvement measure
