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    必須拔除:藥企GMP迎檢的15大風險點

    添加時間:2015-11-02 點擊量:1572

    近日,賽柏藍獲悉福建食藥監局開展的GMP認證跟蹤檢查正在如火如荼地進行。公開資料顯示,福建局本輪的GMP認證跟蹤檢查于9月份開始,11月份結束,共有30家藥企接受GMP認證跟蹤檢查。

    年初,國家食品藥品監管管理總局在對貴州中泰生物科技有限公司的跟蹤檢查中,因發現不符合GMP要求,其GMP證書被收回。

    福建在GMP跟蹤檢查的實施意見中也明確提出,跟蹤檢查實行組長負責制,檢查組一般由2-3GMP認證檢查員組成,其中一名應為熟悉藥品檢驗的人員。跟蹤檢查一般不得提前告知企業。跟蹤現場檢查時間一般為2-3,根據被檢查企業劑型、品種情況可以適當延長現場檢查時間。檢查中發現企業存在嚴重違反GMP規定的,應采取有效措施,責令限期改正或停產整頓,并及時報告省局藥品生產監管處。所以,藥企對此檢查還是相當重視。

    今年是新版GMP認證最后一年,明年11日,未通過新版GMP認證藥企將不得再生產藥品。而從國家局相關負責人在會議上屢次傳出的政策趨勢來看,國家局正對既往的監管模式進行變更,以高強度、有實效的日常監管模式代替以往的重審批,輕監管的管理模式。對藥企飛檢和GMP認證的跟蹤檢查都是其中的例子。

    福建為期兩個月的對30家的藥企GMP認證跟蹤檢查,其實并不是個案,不少省份都在進行GMP認證跟蹤檢查,例如,貴州省的GMP認證跟蹤檢查實施時間為201591日至1225日。還有一些省份在逐漸將之納入到日常的監管中,安徽省食品藥品監督管理局每月發布的對藥企日常監督檢查信息通告中,也常有對藥企GMP認證跟蹤檢查的通告。

    那么,GMP認證跟蹤檢查有那些重點,又有哪些流程呢?下面是賽柏藍從部分省市通知進行的總結,供參考。

    檢查目的:

    嚴格按照新版GMP的要求組織生產,持續地、科學地、全面地抓好藥品質量管理;

    重點對象:

    高風險生產企業、基本藥物生產企業及尚未通過新修訂藥品GMP認證企業,易制毒類特殊藥品生產企業、安全生產重點檢查企業;

    檢查方法:

    跟蹤檢查一律采取飛行檢查的方式,保證檢查真實、有效。亦有省份跟蹤檢查與日常監督檢查相結合,可結合日常監督檢查的重點一并進行檢查;

    檢查重點環節和內容:

    1、上次認證不合格項目的整改情況;

    2、有基本藥物的生產企業要重點檢查基本藥物的生產和質量管理情況;

    3、企業負責人、生產和質量負責人及質量授權人是否有變動,如有變動人員是否符合要求和按要求備案;技術人員隊伍是否符合要求,是否穩定;員工的培訓情況;企業質量受權人制度建立和執行情況,藥品生產企業是否建立生產、質量管理各個環節的責任制度和責任追究制度,并在實際工作中層層落實。

    4、廠房、生產車間、實驗室和設備(重點檢查空氣凈化系統、工藝用水、主要生產和檢驗設備)的使用、維護、保養情況;

    5、物料管理:物料應從符合規定的供應商購進并相對固定,供應商應經評估確定。對供應商評估情況、供應商資質證明文件、質量管理體系情況、購買合同等資料應齊全,并歸檔。藥品生產所用物料的購入、檢驗、貯存、發放、使用等應制定管理制度、藥品生產所用物料應符合相應標準、購進的物料應嚴格執行驗收、抽樣檢驗等程序,并按規定入庫,重點檢查供應商的變更情況;如有提取物投料的供應商資質審計情況;中藥材的采購、供應商審計、檢驗、貯存、投料等;

    6、生產管理:藥品應按照法定標準、生產工藝及SOP組織生產;驗證和再驗證的情況;物料平衡、偏差處理及不合格品處理情況;企業生產設備能否滿足所有生產品種的工藝要求;企業的檢驗設施、設備能否滿足所有品種的檢驗要求,委托的檢驗項目是否符合要求,是否進行了檢驗;對企業倉儲設施和面積能否滿足認生產所有品種的物料(原料、輔料、包材、成品等)的儲存要求,是否根據物料的特性制定相應的儲存、養護措施;企業GMP管理文件能否結合品種特點制定,是否具有針對性和可操作性,審查工藝規程、崗位SOP、批生產記錄等關鍵性文件的針對性、可操作性、合理性以及實際生產過程的吻合性;實際生產崗位是否有具體生產品種的崗位SOP和批生產記錄,是否能夠真實反映和記錄生產過程中的主要控制項目和技術參數;每個劑型至少選擇三個生產批量大、工藝復雜、技術路線長,質量風險高的重點品種,從原輔料的購進、生產過程、檢驗情況等方面進行全面檢查;

    7、委托檢驗:有委托檢驗行為的,受托單位是否具備資質,委托方和受托方是否簽訂合同,是否按規定檢驗,是否在得到委托檢驗項目合格報告書及全部檢驗項目合格后才組織生產;

    8、委托生產(包括中藥提取):有委托生產及受托生產的,重點核查是否有委托生產相關手續;受托方是否具備接受委托生產的能力,是否按委托方的藥品生產工藝組織生產;委托生產或受托生產藥品質量監控情況;

    9、所用原料、輔料、直接接觸藥品的包裝材料是否符合藥用要求;

    10、重點檢查特殊藥品的帳、卡物是否相符,庫存數和特殊藥品監控網絡鎖上數據是否相符;

    11、重點檢查企業涉及危險化學藥品使用、設施設備的防火防爆安全情況

    12、藥品標簽、使用說明書是否與藥品監督管理部門批準的內容、式樣、文字相一致;

    13、各級(食品)藥品監督管理部門對企業違反《藥品管理法》、《藥品生產監督管理辦法》及其他法律法規事項的處理意見或結果;

    14、近年來藥品不良反應監測中發現的高風險品種的生產質量管理情況;

    15、對于因為各種原因要求停產的企業和部分生產線要重點關注。


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