GMP常見英文縮寫

1、GMP常見英文縮寫AQAI(Automated?Quality?Assurance?Inspection?Equipment)在線白動質(zhì)量保證檢查設備API(Active?Pharmaceutical?Ingredient)活性藥物物質(zhì)，即原料藥ANDA?(Abbreviated?New?Drug?Application):簡化新藥申請ADR(Adverse?Drug?Reaction)不良反應BSE(Bovine?Spongiform?Encephalopathy)瘋牛病BPCS(Business?Planning?and?Control?System)k務計劃及控制系統(tǒng)BIA(Busine

2、ss?impact?assessment):商業(yè)影響評估cGMP(current?Good?Manufacturing?Practice)現(xiàn)行藥品生產(chǎn)質(zhì)量管理規(guī)范CCCD(China?Certification?Committee?for?Drugs):中國藥品認證委員會CIP(Cleaning?In?Place)在線清潔CV(Concurrent?Validation):同步驗證CDER(?Center?for?Drug?Evaluation?and?Research)l?品研究與評價中心COA(Certificate?Of?Analysis):分析報告單CFR(Code?of?Federa

3、l?Regulation)套國)聯(lián)邦法規(guī)？CDC(Centers?for?Disease?Control?and?Preventiort):病預防控制中心COS/?CEP(?Certificate?of?Suitability?for?European?Pharmacopeia?)：洲藥典適用性證書CCD?(Certification?Committee?for?Drugs):藥品認證管理中心CPMP(Committee?for?Proprietary?Medicinal?Products):歐洲專利藥品委員會CTD(Common?Technical?Document)通用技術文件CDC(?C

4、enters?for?Disease?Control?and?Prevention疾病預防控制中心GMP(Good?Manufacturing?Practice)藥品生產(chǎn)質(zhì)量管理規(guī)范ICH(International?Conference?on?Harmonization?of?Technical?Requirements?for?Registration?of?Pharmaceuticals?for?Human?Use用藥品注冊技術要求國際協(xié)調(diào)會EU(European?Union):歐洲聯(lián)盟EFPIA(European?Federation?of?PharmaceuticaIndustrie

5、s?Associations)歐洲制藥工業(yè)協(xié)會聯(lián)合會MHW(Ministry?of?Health?and?Welfare,Japan):日本厚生省JPMA(Japan?Pharmaceutical?Manufacturers?Association)3本制藥工業(yè)協(xié)會FDA(US?Food?and?Drug?Adminiistration):美國食品與藥品管理局PRMA(Pharmaceutical?Research?and?Manufacturers?of?Americ豪國藥物研究和生產(chǎn)聯(lián)合會WHO(World?Health?Organization):世界衛(wèi)生組織IFPMA(Internat

6、ional?Federation?of?Pharmaceutical?Manufacturers?Associations):國際制藥工業(yè)協(xié)會聯(lián)合會TQC(Total?Quality?Control),TQM(Total?Quality?Management):?全面質(zhì)量管理PDCA(p_anbobheck>aonx4*JW3JBltfe福QA(Qua=fy2Assurance)wwi£QC2(Qua=fy2confro-，www建QS(Qua=fy2SysCDmxBwwQM(Qua=fy2Managemenf)<www福Sop(sarndard2operafmg2pro

7、cedurew諦灌奮港盅SMP(sarndard2Managemenf?procedur骨諦唬福盅明SOR(sarndard2operafmg2Record)諦灌畜苗部GEP(G00d2Engmeermg2praaceM4港辮HVAC(Heafmg2venf=afo'n2and2>r2condmonmgx盼違<WBDQ(Design2Qua=ficafo's4毒丈-Q(-nsar=afo'n2Qua=ficafo'sm>毒UOQ(operafo'na-2Qua=ficafo'n)-®3PQ(performance2Qu

8、a=ficafo'n)w瞟毒Uoosout?OfSpeMcafo'n，Bin>豉-sswPFDS(process2F_ow2DiagramswN蓋盅座MRA(CMUfua-2ReogMo'n2Agreemenfs)o!Bltw&回凈注DMF(2Drug2Mas(Dr2F=exEDMFmuropean2Drug2Mas(Dr2F畀ISMSWK席EDQM(European?Directorate?for?Quality?MedicineS:?歐洲藥品質(zhì)量管理局ORA(Office?of?Regulatory?Affairs):藥政事務辦公室GGPs(?Good

9、?Guidance?Practices)優(yōu)良指南規(guī)范MOA(Method?Of?Analysis):分析方法VMP(Validation?Master?Plan):驗證主計劃VP(Validation?Protocol):驗證方案MSDS(Material?Safety?Data?Sheet物料安全技術說明書NDA?(New?Drug?Application):新藥申請OTC(Over-thecounter):非處方INN(International?Nonproprietary?Name)國際非專有名稱USP(the?united?state?pharmacopeia庚國藥典NF(Natio

10、nal?Formulary):(美國)國家藥品集GAP(Good?Agricultural?Practice):中藥材種植管理規(guī)范GCP(Good?Clinical?Practice)藥物臨床試驗質(zhì)量管理規(guī)范GLP(Good?Laboratory?Practice)藥物實驗室管理規(guī)范GSP(Good?Supply?Practice圈品經(jīng)營質(zhì)量管理規(guī)范GUP(Good?Use?Practice密品使用質(zhì)量管理規(guī)范SM(Starting?Material):起始物料PMF(Plant?Master?File);?SMF(Site?Master?File)工廠主文件EDL(List?of?Essential?Drugs?)?:?K本藥物目錄PI(Package?Insert說明書PCT(?Patent?Cooperation?Treaty):?利合作條約PPAC(Pa