药品生产质量管理规范认证中企业申请资料缺陷分析与对策建议

Defect Analysis and Countermeasures of Application Documents for GMP Certification of Pharmaceutical Manufacturing Enterprises

目的为药品生产质量管理规范(GMP)认证中企业申请资料的撰写提供参考。方法以GMP认证申请资料技术审查中发现的问题进行缺陷分析,结合GMP检查中的关注点对问题进行梳理。结果形成GMP认证申请资料撰写要点,并举例予以深入阐述,形成示范效果。结论通过申请资料撰写要点的实施,能提升GMP认证企业申请资料的撰写水平,全面、系统、真实地反映企业实际情况。

Objective To provide scientific and feasible suggestions to pharmaceutical manufacturer to write application document of good manufacturing practices(GMP)certification.Methods The problems found in the technical review of application document of GMP cer-tification were analyzed,combined with the focus of GMP inspection,the problems were sorted out.Results The key points of applica-tion document of GMP certification application were formed,and the examples were illustrated for further explanation and demonstration effect.Conclusion By following the key points of application document,the quality of application document could be improved,as well as the real condition of pharmaceutical manufacturing enterprise could be systematically and factually reflected.