聚福彩票
藥監局飛行檢查

藥監局飛行檢查

       CFDA飛行檢查日益頻繁和嚴峻,很多生產企業不符合《醫療器械生產質量管理規范》,經營企業不符合《醫療器械經營監督管理辦法》。

       通過我們對CFDA飛行檢查缺陷的分析,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,切實有效整改,真正提高企業生產和質量管理水平,幫助經營企業通過醫療器械GSP,久順企管正式推出“飛行檢查”咨詢輔導服務。

“飛行檢查”服務概述

       久順企管針對CFDA日益頻繁的飛行檢查,推出的一項新的服務,名為“模擬飛行檢查”,通過對醫療器械企業進行突擊GMP檢查,模擬飛行檢查過程,協助企業發現日常GMP運行過程中存在的典型問題,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。

“模擬飛行檢查”服務的特點

       一.在不告知生產和質量人員的情況下,突擊檢查,以保證飛行檢查模擬的真實性和有效性。

       二.由久順企管選定合適的時間對企業的GMP運行體系進行飛行檢查。

       三.針對檢查結果和企業的特點定制有針對性的整改方案。

       四.根據檢查中暴露的問題對人員進行有效的培訓。

       五.根據首次模擬飛行檢查的結果、整改情況以及企業的特點,久順企管選定合適的時間進行再次模擬飛行檢查,評估整改的有效性和持續性。

       六.持續跟蹤整改情況,確保整改的有效性。

聚福彩票

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