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1、GMP 常见英文缩写AQAI(Automated?Quality?Assura nce?l nspectio n?Equipme nt)在线自动质量保证检查设 备API(Active?Pharmaceutical?lngredient)活性药物物质，即原料药ANDA?(Abbreviated?New?Drug?Application): 简化新药申请ADR(Adverse?Drug?Reactio n)不良反应BSE(Bovi ne?Spo ngiform?E ncephalopathy)疯牛病BPCS(Busi ness?Pla nnin g?a nd?Co ntrol?Systen 业 务
2、计划及控制系统BIA(Busi ness?impact?assessme nt)商业影响评估cGMP(curre nt?Good?Ma nufacturi ng?Practice)现行药品生产质量管理规范CCCD(Chi na?Certificatio n?Committee?for?Drugs):中国药品认证委员会CIP(Clea nin g?I n?Place)在线清洁CV(Co ncurre nt?Validatio n):同步验证CDER(?Ce nter?for?Drug?Evaluati on ?a nd?Research)药品研究与评价中心COA(Certificate?Of?A
3、nalysis): 分析报告单CFR(Code?of?Federal?Regulation)美国)联邦法规？CDC(Ce nters?for?Disease?Co ntrol?a nd?Preve ntior 疾病预防控制中心COS/?CEP(?Certificate?of?Suitability?for?Europea n?Pharmacopeia?欧洲药典适用性证书CCD?(Certificatio n? Committee?for?Drugs):药品认证管理中心CPMP(Committee?for?Proprietary?Medici nal?Products):欧洲专利药品委员会CTD
4、(Com mon ?Tech ni cal?Docume nt)通用技术文件CDC(?Ce nters?for?Disease?Co ntrol?a nd?Preve ntio n 疾病预防控制中心GMP(Good?Ma nu facturi ng?Practice)药品生产质量管理规范ICH(International?Conference?on?Harmonization?of?Technical?Requirements?for?Registration ?of?Pharmaceuticals?for?Huma n?Use 人用药品注册技术要求国际协调会EU(Europea n?Un i
5、o n):欧洲联盟EFPIA(Europea n?Federati on ?of?Pharmaceutical ndustries?Associatio ns)欧洲制药工业协会联合会MHW(Mi nistry?of?Health?a nd?Welfare,Japa n):日本厚生省JPMA(Japa n?Pharmaceutical?Ma nufacturers?Associatio n 日本制药工业协会FDA(US?Food?a nd?Drug?Admi ni istratio n):美国食品与药品管理局PRMA(Pharmaceutical?Research?a nd?Ma nufactu
6、rers?of?Americ 美 国药物研究和生产联合会WHO(World?Health?Orga nizati on):世界卫生组织IFPMA(I ntern ati on al? Federati on? of? Pharmaceutical? Manu facturers?Associatio ns):国际制药工业协会联合会TQC(Total?Quality?Co ntrol),TQM(Total?Quality?Ma nageme nt):?全面质量管理7ReognMon7Agreemenfs)vBltw&anPFDS(pocess7F_ow7Diagams口沁酉谕HMRA(CM&ua
7、-oos(oufofspecificafionrBgsn7Qua=ficafiony3-sswPQ(perfonnance7Qua-ificafion)wafion7Qua=ficafionyDQ(Design7Qua=ficafiony蛊芦菇斗OQ(ope蛊芦afiona-Q(-nsar-HVAC(Heafing7venfi-afion7and7ncondmoningysSop(sarndas.7ope哺J!afing7poceduewmySww(Qwu观QM(Qua=fy7Managemenf)vwwa-ify7SysCDce)QW渝wA(Qfe?umlQC7(Qua-ify7confa-
8、ify7Assuo-rwwwranPDCA(p_apDObhecKAaony斗&_JW3MQDMFC?DnJg7Mas(D7F=eyISMSWK运H)EDQM (European?Directorate?for?Quality?MedicineS :?欧洲药品质量管理局ORA(Office?of?Regulatory?Affairs): 药政事务办公室GGPs(?Good?Guida nce?Practices)优良指南规范MOA(Method?Of?Analysis): 分析方法VMP(Validati on ?Master?Pla n):验证主计划VP(Validatio n?Protoc
9、ol):验证方案MSDS(Material?Safety?Data?Sheet 物 料安全技术说明书NDA?(New?Drug?Application): 新药申请OTC(Over-th&cou nter):非处方INN(I nternatio nal? Non proprietary?Name)国际非专有名称USP(the?u nited?state?pharmacopeia 美 国药典NF(Natio nal?Formulary):(美国)国家药品集GAP(Good?Agricultural?Practice):中药材种植管理规范GCP(Good?Cli ni cal?Practice)药
10、物临床试验质量管理规范GLP(Good?Laboratory?Practice)药物实验室管理规范GSP(Good?Supply?Practice 药品经营质量管理规范GUP(Good?Use?Practice)药品使用质量管理规范SM(Starti ng?Material):起始物料PMF(Pla nt?Master?File);?SMF(Site?Master?File)工厂主文件EDL(List?of?Esse ntial?Drugs?)?:?基本药物目录PI(Package?l nsert)说明书PCT(?Pate nt?Cooperatio n?Treaty)专利合作条约PPAC(Pate nt? Protectio n? Association ?of? Chi na 中国专利保护协会PIC(?Person ?ln? Charge)?负责人PDS(Pharmaceutical? Developme nt? Services)整体新药研发机构SPC(Summary ?of? Product? Characteristics 产品特性摘要