基于EBGMP理念的药品GMP认证现场检查工作分析

目的 基于循证GMP认证工作(EBGMP)理念分析药品GMP认证现场检查工作.方法 通过分析循证理念在药品GMP认证现场检查工作中的应用概况及药品GMP认证现场检查工作中的疑问提出不积极、证据收集不全面、证据评估不充分、效果评价不到位等循证不足,探讨证据依循不足可能诱发的药品GMP认证现场检查工作风险.结果 在药品GM...

Analysis of drug GMP certification on-site inspection in the light of EBGMP idea

Objective To analyze drug GMP certification on-site inspection in the light of EBGMP（evidence based GMP） idea.Methods Evaluate the practice of evidence based idea in the drug GMP certification on-site inspection and the defects of evidence based practice in the drug GMP certification on-site inspection such as less doubt,incompleteness of the evidence,inadequacy of evidence evaluation,imperfection of the evaluation of policy effect.Then study the risk of drug GMP certification on-site inspection from the defects of evidence based practice.Results The defects of evidence based practice can bring risks to drug GMP certification on-site inspection,such as problem omission risk,misjudge risk,low work efficiency risk.Conclusion More and better training on the technology of evidence based practice for GMP inspector,development of evidence bank,the perfection of feedback system about the result of on-site inspection can be used to correct the defects of evidence based practice in the drug GMP certification on-site inspection and decrease the risks from those defects.