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为解决在中国制药企业实行质量受权人制度的困惑及如何寻找出路以确保药品企业生产的合规性,本文从一个中国首批受权人的视角,借鉴国外的先进经验,根据中国国情,对制药企业在现阶段实行质量受权人制度的现状和要求,进行了深入的探讨和分析,提出了即符合中国国情,又能有效保障药品质量的具体操作方法,以期推进制药企业质量受权人制度在中国的健康发展。
In order to solve the puzzledom of implementing quality attorney system in Chinese pharmaceutical companies and how to find a way out to ensure the compliance of pharmaceutical enterprises, this article draws on the experiences of the first batch of attorneys in China, draws on the advanced experience of other countries and according to China’s national conditions, The status quo and requirements of the quality attorney system implemented by the enterprises at this stage are discussed and analyzed in depth, and specific operational methods that are in line with China’s national conditions and effectively guarantee the quality of the pharmaceutical products are put forward in order to promote the system of quality attorneys in pharmaceutical enterprises in China The healthy development.