“GMP”是英文(wen)Good Manufacturing Practice的(de)(de)(de)縮寫(xie),中(zhong)(zhong)(zhong)文(wen)的(de)(de)(de)意思是“良好作(zuo)(zuo)業規(gui)范(fan)”,或是“優良制(zhi)(zhi)造標準”,是一種(zhong)特別注重制(zhi)(zhi)造過程中(zhong)(zhong)(zhong)產(chan)(chan)(chan)品(pin)(pin)質(zhi)量(liang)(liang)與衛(wei)(wei)生(sheng)(sheng)安全(quan)的(de)(de)(de)自(zi)主性管(guan)(guan)理制(zhi)(zhi)度(du)。 它是一套適(shi)用于(yu)制(zhi)(zhi)藥(yao)(yao)(yao)、食(shi)品(pin)(pin)等(deng)行(xing)業的(de)(de)(de)強制(zhi)(zhi)性標準,要求企(qi)業從原料(liao)、人員、設(she)施設(she)備、生(sheng)(sheng)產(chan)(chan)(chan)過程、包(bao)裝運輸、質(zhi)量(liang)(liang)控制(zhi)(zhi)等(deng)方面按國(guo)(guo)(guo)(guo)家(jia)(jia)有關(guan)法(fa)規(gui)達(da)到衛(wei)(wei)生(sheng)(sheng)質(zhi)量(liang)(liang)要求,形成一套可操作(zuo)(zuo)的(de)(de)(de)作(zuo)(zuo)業規(gui)范(fan)幫助企(qi)業改善(shan)企(qi)業衛(wei)(wei)生(sheng)(sheng)環境,及時發(fa)(fa)現(xian)生(sheng)(sheng)產(chan)(chan)(chan)過程中(zhong)(zhong)(zhong)存(cun)在的(de)(de)(de)問(wen)題,加(jia)以改善(shan)。中(zhong)(zhong)(zhong)國(guo)(guo)(guo)(guo)衛(wei)(wei)生(sheng)(sheng)部于(yu)1995年7月11日下達(da)衛(wei)(wei)藥(yao)(yao)(yao)發(fa)(fa)(1995)第35號"關(guan)于(yu)開(kai)展藥(yao)(yao)(yao)品(pin)(pin)GMP認(ren)(ren)證工作(zuo)(zuo)的(de)(de)(de)通知(zhi)"。藥(yao)(yao)(yao)品(pin)(pin)GMP認(ren)(ren)證是國(guo)(guo)(guo)(guo)家(jia)(jia)依法(fa)對藥(yao)(yao)(yao)品(pin)(pin)生(sheng)(sheng)產(chan)(chan)(chan)企(qi)業(車間(jian))和藥(yao)(yao)(yao)品(pin)(pin)品(pin)(pin)種(zhong)實(shi)施GMP監(jian)督(du)檢查并取(qu)得(de)認(ren)(ren)可的(de)(de)(de)一種(zhong)制(zhi)(zhi)度(du)。雖然國(guo)(guo)(guo)(guo)際上藥(yao)(yao)(yao)品(pin)(pin)的(de)(de)(de)概念包(bao)括獸(shou)藥(yao)(yao)(yao),但只有中(zhong)(zhong)(zhong)國(guo)(guo)(guo)(guo)和澳大利亞等(deng)少數幾個國(guo)(guo)(guo)(guo)家(jia)(jia)是將人用藥(yao)(yao)(yao)GMP和獸(shou)藥(yao)(yao)(yao)GMP分開(kai)的(de)(de)(de)。 藥(yao)(yao)(yao)品(pin)(pin)GMP認(ren)(ren)證分為國(guo)(guo)(guo)(guo)家(jia)(jia)和省兩級進行(xing),根據《中(zhong)(zhong)(zhong)華(hua)人民(min)共和國(guo)(guo)(guo)(guo)藥(yao)(yao)(yao)品(pin)(pin)管(guan)(guan)理法(fa)實(shi)施條例》的(de)(de)(de)規(gui)定,省級以上人民(min)政府藥(yao)(yao)(yao)品(pin)(pin)監(jian)督(du)管(guan)(guan)理部門(men)(men)應當按照《藥(yao)(yao)(yao)品(pin)(pin)生(sheng)(sheng)產(chan)(chan)(chan)質(zhi)量(liang)(liang)管(guan)(guan)理規(gui)范(fan)》和國(guo)(guo)(guo)(guo)務(wu)院藥(yao)(yao)(yao)品(pin)(pin)監(jian)督(du)管(guan)(guan)理部門(men)(men)規(gui)定的(de)(de)(de)實(shi)施辦法(fa)和實(shi)施步驟,組織對藥(yao)(yao)(yao)品(pin)(pin)生(sheng)(sheng)產(chan)(chan)(chan)企(qi)業的(de)(de)(de)認(ren)(ren)證工作(zuo)(zuo);符合《藥(yao)(yao)(yao)品(pin)(pin)生(sheng)(sheng)產(chan)(chan)(chan)質(zhi)量(liang)(liang)管(guan)(guan)理規(gui)范(fan)》的(de)(de)(de),發(fa)(fa)給認(ren)(ren)證證書。其中(zhong)(zhong)(zhong),生(sheng)(sheng)產(chan)(chan)(chan)注射劑、放射性藥(yao)(yao)(yao)品(pin)(pin)和國(guo)(guo)(guo)(guo)務(wu)院藥(yao)(yao)(yao)品(pin)(pin)監(jian)督(du)管(guan)(guan)理部門(men)(men)規(gui)定的(de)(de)(de)生(sheng)(sheng)物制(zhi)(zhi)品(pin)(pin)的(de)(de)(de)藥(yao)(yao)(yao)品(pin)(pin)生(sheng)(sheng)產(chan)(chan)(chan)企(qi)業的(de)(de)(de)認(ren)(ren)證工作(zuo)(zuo),由(you)國(guo)(guo)(guo)(guo)務(wu)院藥(yao)(yao)(yao)品(pin)(pin)監(jian)督(du)管(guan)(guan)理部門(men)(men)負責。
1、防止不同藥(yao)物(wu)或其成(cheng)份之間(jian)發生混雜(za);
2、防止由其它藥物或其它物質帶來的交叉污染;防止差(cha)錯與計量傳(chuan)遞和信(xin)息傳(chuan)遞失真(zhen);
3、防止遺漏任何檢(jian)驗步驟的事(shi)故發生(sheng);
4、防止任(ren)意操作及不執行(xing)標準與低限投(tou)料等違章(zhang)違法事故發生;
5、制訂和實施GMP的主要目的是(shi)(shi)為(wei)(wei)了保護消費(fei)者(zhe)的利益,保證人們用藥安全有(you)(you)效(xiao);同時也是(shi)(shi)為(wei)(wei)了保護藥品生產企業,使企業有(you)(you)法(fa)可(ke)依、有(you)(you)章可(ke)循;另外,實施GMP是(shi)(shi)政(zheng)府和法(fa)律賦(fu)予制藥行業的責(ze)任,并(bing)且也是(shi)(shi)中(zhong)國加入WTO之(zhi)后,實行藥品質量保證制度(du)的需(xu)要。