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藥品FDA驗廠總則

藥品FDA驗廠總則

       FDA GMP CFR 210 & CFR 2ll驗廠 

       FDA是美國食品藥物管理局(Food and Drug Administration)的英文縮寫,它是國際醫療審核權威機構,由美國國會即聯邦政府授權,專門從事食品與藥品管理的最高執法機關。 

       FDA是一個由醫生、律師、微生物學家、藥理學家、化學家和統計學家等專業人事組成的致力于保護、促進和提高國民健康的政府衛生管制的監控機構。

       就原料藥而言,FDA檢查目的是為了保證從國外進口的原料藥的質量充分符合USP的要求,美國政府規定外國的藥物生產商向美國出口藥物產品,除了要對該產品的樣品進行質量檢查之外,還要對藥物制造企業的相關設施進行檢查才能做出批準與否的決定,FDA現場檢查由此而生。

       FDA驗廠主要分為三類:

       一是批準前的現場檢查(Pre—approval Inspection),即我們通常說的“FDA驗廠”, 對新藥和仿制藥品的生產采取的檢查行動;

       二是定期檢查(Biennial),對批準后的藥品進行定期合規性檢查,通常兩年進行一次;

       三是基于投訴、召回或不良反應FDA臨時決定進行專門的檢查或監督。

       FDA驗廠的依據起源于是美國國會1938年頒發的聯邦食品、藥品和化妝品法案(常縮寫為FFDCA,FDCA,或FD&C), 該法案賦予美國食品藥品監督管理局(FDA)監督監管食品安全、藥品、及化妝品的權力。

       關于藥品方面,主要是受“食品、藥物及化妝品法案”第501款(a)(2)(b)的管制,即所有藥物的制造、加工和包裝,均要嚴格符合cGMP的要求。

       GMP制度在聯邦法規(code 0f Federal Regulations)中的CFR 210條款和CFR 2ll條款中有具體規定。不過,自發布以來的GMP主要是為制劑藥而制定的。在它的前言中說明:雖然它不是用于原料藥,但有許多實例說明對原料藥的GMP要求是與CFR 2ll條款中所制定的要求很近似。因此,FDA就采用CFR 2ll條款作為規范來對原料藥廠進行檢查。在這點上,FDA對原料藥與制劑藥的要求都是一樣的嚴格,沒有區別。1997年9月,國際協調會議(ICH:InternationalConference 0f Harmonization)公布了專為原料藥制定的GMP草案,更切合原料藥的生產實際。

       2001年8月,美國健康人類服務部食品藥物管理局藥物評價研究中心和生物制品評價研究中心與國際協調會議聯合發布了用于活性藥物成分(原料藥)生產的GMP指南:Guidance for Industry Q7A—Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients),即Q7A GMP。此后,FDA宣布以這個指南文件為原料藥生產的GMP統一標準,并以此對原料藥廠進行符合性檢查。

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