我国GMP认证申报资料与PIC/S工厂主文档的比较

Comparison Between Application Documents for China GMP Certification and PIC/S Site Master File

目的借鉴PIC/S工厂主文档的内容要求,为完善我国GMP认证申报资料提供建议。方法比较我国GMP认证申报资料和工厂主文档的差异。结果与结论我国GMP认证申报资料应当与时俱进的增加相应内容和要求,如产品疑为假药/劣药后的处理方法描述等。

Objective To provide authoritative advice on improving application documents for China GMP certification through referencing to site master file requirements.Methods The differences were compared between application documents for China GMP certification and PIC/S site master file.Results and Conclusion The application documents for China GMP certification should be improved base on the latest requirements and timely information need to be added such as the introduction of measures adopted to counterfeit or falsified products that are suspected or identified.