本文对我国的GMP检查评定标准进行了历史回顾和利弊分析,并介绍了PIC/S、加拿大、美国等国外以风险评估为原则的检查缺陷分类方法、系统评估要求和检查评定标准,探讨我国今后GMP认证评定标准的改进方向和思路,提出了对我国药品GMP检查评定标准的修改建议。
<<Three versions of China Evaluation Criteria for GMP Inspection are reviewed and its advantages and disadvantages are analyzed. Classification for deficiencies by risk-based approach,systematic evaluation requirement and criteria for inspection result from PIC/S,Canada and U.S.A related guidelines are introduced. The direction and method on improvement of China Evaluation Criteria for GMP Inspection are discussed. Suggestions on how to revise the criteria are proposed.
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