GMP,Good Manufacturing Practice （優(yōu)良的生產(chǎn)實(shí)踐）藥品生產(chǎn)質(zhì)量管理規(guī)范,目錄,GMP,G M P“Good Manufacturing Practice” means that a pharmaceutical manufacturer proves that he is in control of all processes involved to manufacture a medicine and can guarantee that the final product complies with all requirements. “GMP標(biāo)準(zhǔn)”是所有在市場上銷售藥品和醫(yī)療器械的強(qiáng)制性生產(chǎn)制造標(biāo)準(zhǔn)。 “（優(yōu)良的生產(chǎn)實(shí)踐）藥品生產(chǎn)質(zhì)量管理規(guī)范”表示一個制藥企業(yè)有能力加工某種藥品，并且可以保證最終的產(chǎn)品符合所有的要求。,Government Authorities around the world are not satisfied by the word of anybody, they want to make sure that the pharmaceutical manufacturer is able to fulfill his guarantee.全世界的政府權(quán)威部門對任何人的描述都不滿意，他們希望確定醫(yī)藥制造商能夠履行對于質(zhì)量的保證。To insure this guarantee, they have set up regulations for pharmaceutical manufacturers and they are sending inspectors in to check that these regulations are in place and not bypassed.為了確保質(zhì)量，他們制定了針對醫(yī)藥制造商的法規(guī)，并派遣審查官員檢查這些法規(guī)的落實(shí)。,GMP來源,These inspectors or “auditors” as they are called will issue the GMP license after they have audited a manufacturing facility and have been satisfied that the audited pharmaceutical manufacturer can give the required guarantee.這些檢查員或“審計(jì)員”在檢查過制造設(shè)備，并對提供質(zhì)量保證滿意后頒發(fā)GMP證書。,TheGMP license is like a drivers license. GMP證書就象一張駕照。It is completely irrelevant if you can drive or not. Without a license you are not allowed to drive.這不是您可不可以駕駛的問題。而是沒有這張駕照在法律上就意味著不允許駕駛。,G M P要求企業(yè)建立工程設(shè)備系統(tǒng)質(zhì)量管理系統(tǒng)實(shí)驗(yàn)室控制系統(tǒng)物料管理系統(tǒng)生產(chǎn)管理系統(tǒng)衛(wèi)生管理系統(tǒng)組成的質(zhì)量體系來防止生產(chǎn)過程存在污染、交叉污染、混淆和差錯等風(fēng)險(xiǎn)。,文件,GMP對質(zhì)量管理部門賦予權(quán)威，與質(zhì)量有關(guān)的文件都要由質(zhì)量管理部門審核、批準(zhǔn)。GMP要求貫穿整個生產(chǎn)過程的嚴(yán)格、詳細(xì)的文件：比如操作人員動作文件化指定發(fā)放中間體的人員,記錄,所有有關(guān)產(chǎn)品質(zhì)量的活動都應(yīng)被記錄。任何偏離文件的情況都應(yīng)有文字記錄并加以解釋。對關(guān)鍵性的偏差進(jìn)行調(diào)查，記錄調(diào)查經(jīng)過及結(jié)果，分析原因，并制定預(yù)防整改措施記錄應(yīng)確保清楚、準(zhǔn)確、可追溯，關(guān)鍵數(shù)字的修改應(yīng)注明原因并經(jīng)過批準(zhǔn)。,驗(yàn)證,以數(shù)據(jù)說話，與質(zhì)量有關(guān)的計(jì)量器具需經(jīng)校驗(yàn)合格后方可使用。生產(chǎn)、檢驗(yàn)、物流全過程都需要經(jīng)過驗(yàn)證審評，有充分的數(shù)據(jù)支持，驗(yàn)證方法符合相關(guān)指南如清潔驗(yàn)證指南潔凈區(qū)環(huán)境監(jiān)測方法等。每年進(jìn)行質(zhì)量回顧，根據(jù)評估結(jié)果制定措施如今后的行動線（OOT值）。,Clean,The most important is Clean. All