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藥監局GMP體系考評

藥監局GMP體系考評

       國家藥監局于2014年09月05日發布了《醫療器械生產質量管理規范》,又于2015年09月25日印發了4個《醫療器械生產質量管理規范現場》檢查指導原則,體系要求越來越規范化,對體系的要求越來越嚴苛。

       很多新的企業在注冊時通不過藥監局的體系監督檢查,以至于拿不到產品注冊證和生產許可證;老的企業被抽檢或飛行檢查時,體系達不到法規的要求,被責令限期整改甚至停產整改。

       通過我們對SFDA體系核查的分析,這些缺陷并非全部是技術的難題。根據久順企管將近20年的GMP咨詢經驗,很多企業也或多或少存在類似的問題,有一些企業知道自己有問題,但是不知道如何有效整改;一些企業可能沒有意識到自己的問題,這兩種情況都是非常可怕的。

       為了幫助醫療器械企業找到自己問題的根源,通過藥監局的監督審查,提升企業的質量管理水平,久順企管為生產企業提供“藥監局驗廠”咨詢輔導服務。

“藥監局GMP體系考評”服務概述

久順企管根據CFDA發布的《醫療器械生產質量管理規范》和4個《醫療器械生產質量管理規范現場》檢查指導原則。通過對醫療器械企業進行質量管理體系輔導,協助企業建立體系、發現日常GMP運行過程中存在的問題,并且為其提出整改建議,幫助醫療器械企業全面提升質量管理水平,保證GMP的有效運行。

“藥監局驗廠”服務如下

       一.建立生產質量管理體系;

       二.針對企業的特點制定有針對性的現場整改方案;

       三.實施、完善生產質量管理體系;

       四.對人員進行有效的培訓;

       五.內審模擬審核;

       六.通過藥監局體系核查。

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