GMP常见英文缩写教学文案.docVIP

GMP常见英文缩写 AQAI(Automated?Quality?Assurance?Inspection?Equipment):在线自动质量保证检查设备 API(Active?Pharmaceutical?Ingredient):活性药物物质,即原料药 ANDA?(Abbreviated?New?Drug?Application):简化新药申请 ADR(Adverse?Drug?Reaction):不良反应 BSE(Bovine?Spongiform?Encephalopathy):疯牛病 BPCS(Business?Planning?and?Control?System):业务计划及控制系统 BIA(Business?impact?assessment):?商业影响评估 cGMP(current?Good?Manufacturing?Practice):现行药品生产质量管理规范 CCCD(China?Certification?Committee?for?Drugs):中国药品认证委员会 CIP(Cleaning?In?Place):在线清洁 CV(Concurrent?Validation):同步验证 CDER(?Center?for?Drug?Evaluation?and?Research):?药品研究与评价中心 COA(Certificate?Of?Analysis):分析报告单 CFR(Code?of?Federal?Regulation):(美国)联邦法规? CDC(Centers?for?Disease?Control?and?Prevention):疾病预防控制中心 COS/?CEP(?Certificate?of?Suitability?for?European?Pharmacopeia?):欧洲药典适用性证书 CCD?(Certification?Committee?for?Drugs):药品认证管理中心 CPMP(Committee?for?Proprietary?Medicinal?Products):?欧洲专利药品委员会 CTD(Common?Technical?Document):通用技术文件 CDC(?Centers?for?Disease?Control?and?Prevention):?疾病预防控制中心 GMP(Good?Manufacturing?Practice):药品生产质量管理规范 ICH(International?Conference?on?Harmonization?of?Technical?Requirements?for?Registration?of?Pharmaceuticals?for?Human?Use):人用药品注册技术要求国际协调会 EU(European?Union):欧洲联盟 EFPIA(European?Federation?of?Pharmaceutical Industries?Associations):欧洲制药工业协会联合会 MHW(Ministry?of?Health?and?Welfare,Japan):日本厚生省 JPMA(Japan?Pharmaceutical?Manufacturers?Association):日本制药工业协会 FDA(US?Food?and?Drug?Adminiistration):美国食品与药品管理局 PRMA(Pharmaceutical?Research?and?Manufacturers?of?America):美国药物研究和生产联合会 WHO(World?Health?Organization):世界卫生组织 IFPMA(International? Federation? of? Pharmaceutical? Manufacturers?Associations): 国际制药工业协会联合会 TQC(Total?Quality?Control),TQM(Total?Quality?Management):?全面质量管理 PDCA(Plan,Do,Check,Action):计划,执行,检查,处理 QA(Quality?Assurance):质量保证 QC?(Quality?Control):质量控制 QS(Quality?System):质量体系 QM(Quality?Management):?质量管理 SOP(Standard?Operating?Procedure):?标准操作规程 SMP(Standard?Management?Procedure):标准管理程序 SOR(Standard?Operating?Record):?标准操作记录 GEP(Good?Engineering?Practic