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美國藥品cGMP認證

美國藥品cGMP認證 

一、美國cGMP認證介紹

       1. 名稱:cGMP即Current Good Manufacture Practices, 現行GMP的簡稱。cGMP要求在產品的生產和物料的全過程都必須驗證。美國FDA執行cGMP在國際上有較高的權威性,所以產品若得到美國cGMP認證, 在國際市場上常常身價倍增。在藥品市場日趨國際化的今天,企業獲得美國cGMP認證已是大勢所趨。

       美國食品藥品管理局(Food and Drug Administration簡稱FDA) 認證是進入美國市場的“準入證”;通過FDA認證的食品、藥品、化妝品和醫療器具,在美國等近百個國家,是作為認可的憑證的,因此,可以實現“一勞永逸”。

二、美國cGMP法規主要內容

A. 總則

B. 組織與人員

C. 廠房和設施

D. 設備

E. 成分、藥品容器和密封件控制

F. 生產和加工控制

G. 包裝和標簽控制

H. 貯存和銷售

I. 實驗室控制

J. 記錄和報告

k. 退回的藥品和回收處理

三、常見問題

       1. FDA注冊是否一定需要一位美國代理人?

       答:是的,中國申請人在進行FDA注冊時必須指派一名美國公民(公司/社團)作為其代理人,該名代理人負責進行位于美國的過程服務,是聯系FDA與申請人的媒介。

       2. 中美GMP檢查方式有哪些不同?

       答:據專家介紹,我國的GMP規范中要求檢查員面面俱到,覆蓋面廣,重點不突出,對藥品生產企業的很多具體操作,如設備確認和驗證、工藝驗證、分析方法驗證、無菌工藝驗證等影響產品質量的關鍵工藝沒有制定詳細的操作規范,往往會造成檢查員忽略對這些關鍵環節的檢查,如檢查員在倉儲區檢查,往往根據現場實際,抽出幾個品種的管理情況,調取其主要成分或輔料的有關信息以備生產管理檢查所需。實際上,這種抽查手段所得到的信息量非常少,難免以偏概全,很難摸清企業的實際情況,為企業弄虛作假提供了機會。同樣,對生產管理的檢查,也有脫節情形,如檢查人員在生產現場往往無法看到完整的批生產記錄,從而無從了解生產的實際情況,也就不能發現企業的客觀缺陷。

四、久順企管集團(中國 英國 愛爾蘭)的服務流程

       發出《客戶資料表》→評估(電話、郵件、現場)→出具合同和計劃表→簽訂合同→現場診斷→分析原因→進行cGMP知識培訓→成立cGMP作小組→討論并制作cGMP工作分工及進度表→指導客戶準備cGMP文件→cGMP文件運行→體系運行檢查進行→專家預檢→申請美國cGMP認證→迎檢→根據CAPA情況進行回復等→獲得cGMP證。

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