通过国际药品GMP认证的药品生产企业调研情况分析  

A Survey on Pharmaceutical Manufacturing Enterprises Certificated by International Drug GMP Inspections

作　　者：毕军[1] 陈佩毅[1] 沈传勇[2] 翟铁伟[2] 樊晓东[2] 魏澜[2] 

机构地区：[1]广东省食品药品监督管理局审评认证中心,广州510080 [2]国家食品药品监督管理总局食品药品查验中心

出　　处：《中国药事》2014年第9期954-958,共5页Chinese Pharmaceutical Affairs

摘　　要：目的掌握国际药品生产质量管理规范(GMP)认证检查情况,为我国药品检查政策的制定和药品检查体系建设提供依据。方法由17家省级药品检查机构对全国通过国际药品GMP认证的药品生产企业进行全面调研,方式包括问卷和实地调研。结果与结论国际认证更注重企业体系管理的完整性,国内认证过程则多注重具体条款的执行情况。建议借鉴国际认证检查方法,提高我国药品GMP检查员认证检查能力,探索认证检查改革程序,加强对药品质量相关支持系统的建设和管理,为企业提供国际认证相关培训和交流机会,从国家层面提高药品监管水平,对通过国际认证的企业给予政策支持,及时组织人员翻译国际药品GMP认证检查相关法律法规或者技术指南,改进我国的药品认证检查工作。Objective To understand the inspection status of international drug GMP certification and provide basis for establishment of drug inspection policy and construction of drug inspection system in China.Methods A comprehensive investigation was conducted by 1 7 provincial drug inspection institutions on pharmaceutical manufacturing enterprises certificated by international drug GMP in China. Questionnaire and on-the-spot investigation were performed. Results and Conclusion International certification paid more attention to the integrity of the enterprise system management while domestic certification attached more attention to the implementation of specific terms in the process of certification. In order to improve the pharmaceutical inspection work in China,it was recommended to take international certification inspection methods for reference to raise the inspector＇s competence of inspection,explore the a form on national certification inspection,improve the support system of drug quality,strengthen training and international exchange,improve the whole supervision level over drug throughout the country,give policy support to pharmaceutical companies which have passed the GMP inspection of WHO and so on,as well as provide prompt introduction of the international laws and regulations and guidelines related to GMP.

关 键 词：药品生产质量管理规范 国际认证 药品生产企业 检查方法 调查研究 

分 类 号：R95[医药卫生—药学] R954.2