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目的为了完善药品无菌检查方法验证工作,规范方法验证资料书写,营造资源共享环境。方法对收集的方法验证资料进行审核统计、分析和讨论,提出建议。结果收集的方法验证资料较为凌乱、遗漏多,可操作性差,影响药品无菌检查工作。结论加强药品无菌检查方法验证工作的指导和管理,完善方法验证及资料书写规范化。
Objective In order to improve the verification of the method of sterility testing of medicines, standardize the methods of verifying data writing and create a resource sharing environment. Methods The verification methods of collected data were reviewed, analyzed and discussed, and suggestions were made. Results collection method to verify the information is more messy, omissions, maneuverability is poor, affecting the sterile test drugs. Conclusion Strengthen the guidance and management of the validation of the method of sterility testing of medicines, improve the method verification and standardization of data writing.