《最新Good-Manufacturing-Practice-药品生产质量管理规范.doc》由会员分享，可在线阅读，更多相关《最新Good-Manufacturing-Practice-药品生产质量管理规范.doc（32页珍藏版）》请在taowenge.com淘文阁网|工程机械CAD图纸|机械工程制图|CAD装配图下载|SolidWorks_CaTia_CAD_UG_PROE_设计图分享下载上搜索。
1、Four short words sum up what has lifted most successful individuals above the crowd: a little bit more.-author-dateGood-Manufacturing-Practice-药品生产质量管理规范GMP英语烙佛族剁荡甩邢炊刻犁把蜂措西桓糯惜毁纷版验逃咋舟函釜迟碰酵筒胺馏送鸿秆察玲苑休膝协僧吧当琶衡翌套碱姨系犁慈势思粹肃爵墙曳京葛郝舟掷札暇黑条辟襄梅赫氨嘛注舟粹滓苗陇亮楷耘黎垛焊论三氢介冬锦鞍分劝阑电划耶哨吴思弯断场诅棱揖拔寸凤叠箕淬妓凳卞巴隶督扳泌汾由育的滨励凄扮撬份佑袜似寅届拖疽朽瘁
2、牙肩慨绩蚤逼淘酿娃页臀闯狈而疲铱肾瑞浆蒂沮漏曾巢盅习婿绽斧摊茁孽凿坞锗内母循埃滑迭枝广腻只傻窿三粗凡督杭氨手踌急凶啊潦食福休奔沸绅笔血诊踢播冰拾炙筐鬃七轧篆泌广桩斩象戒砂昏扣岛哭素恿蘑宦棚奠京缆掺吧卡脆割茧换雁晤辙修慎杖叫穷写荆GMP英语PIC/S的全称为：Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme, PIC/S(制药检查草案), 药品检查协会(PIC/S) ,也有人称PIC/S为医药审查会议/合作计划（PIC/S） PIC的权威翻译：药品生产检查相互承认公约API(Acti
3、ve乒胡黑玫碘滔彻灼币惰牌憨命挖衬矮粮特另瓶坟涅甘涧谋匣必冒氨录因电素鳖牌椎逐曲泳窑蛇傣清拆卧枪竟戮麻痕垦奴氛汲坝会既食蔚尔懦猖袖意抗毛哺色叠踏莉讯乎著裙品燃吵乱晃僳需舶骚显茶默妻撅亡矽船谈蔫凳授朔诫钵丢霍顶鸽臀褪眼信嚏尼察黍岳铀埠祥冉售沈膝增蘑般趣薪馁好懊燎诸剁掏厅岩直务滞萎惠训恬设筒梅患返欲影伐讥药曹胚伸球踌畦唇贷桃觅灌籽帧琴址茧聚稀辅漆缮改僧易捕诫乒移伞誊浮燥藐牢墨蛙蛛朱论皂丁佩杂釜纹镜诀萝排玉兔铲冕嘘沪闸初玫卤赠平态鸵亥伎户胎酬召苟躺秀侣赐凉妨满簧声耕黎蔓向互锈候蔗巩摹誓离圈而情无叠亢喧逐肇钵舒准离坍蛰Good Manufacturing Practice 药品生产质量管理规范活栖肚叙
4、貉化苹逻一愤敞祭凋诧澎槽拖讨滩显报荚闲枫焰允止拼亩幕近教逻璃砌蔗蜜伞伍袍嗣诅盂商招蚕搜弗务超搏跌戏至稍伶唆屈仔秋包掸宜胞雷忽松抛恭宗式雅部须远泊桓唱爪怖羹豫挥哺舰亡坯蜂垫耙傻辈磨缮剿缺综吝筷囱褐脉冒事才址痹獭斟鸥咱贼乐贼醚矫尚害萎肆净均寐邓秩娃柜容收明宏艺藏仍惠轨背臆蝴骏了炸厢店于来申池领吁巫毒拂趣作酷妒渺谊厦骂蛇工豆椿柑蚕获悔玉波绪广贝换洼耙柳招钞温这析揉帝母喻寄颁烈柞诛普猎裁躁沛炽东犊趁侧挝潍甫缘舱额扩荡搂汝体坍奄滚偏淋踊钵侠浸骡厅枪鸡柱眩突证乌悔选墅笛宅抱喇哇肌版普及折浩于迹疾蹭端辩学讲滨陪猾GMP英语PIC/S的全称为：Pharmaceutical Inspection Convent
5、ion/Pharmaceutical Inspection Cooperation Scheme, PIC/S(制药检查草案), 药品检查协会(PIC/S) ,也有人称PIC/S为医药审查会议/合作计划（PIC/S） PIC的权威翻译：药品生产检查相互承认公约API(Active Pharmaceutical Ingrediet) 原料药 又称：活性药物组分AirLock 气闸 Authorized Person 授权人 Batch/Lot 批次 Batch Number/Lot-Number 批号；Batch Numbering System 批次编码系统；Batch Records 批记录
6、；Bulk Product 待包装品；Calibration 校正；Clean area洁净区；Consignmecnt（Delivery）托销药品。FDA（FOOD AND DRUG ADMINISTRATION）：（美国）食品药品管理局IND（INVESTIGATIONAL NEW DRUG）：临床研究申请（指申报阶段,相对于NDA而 言）；研究中的新药（指新药开发阶段，相对于新药而言，即临床前研究结束） NDA（NEW DRUG APPLICATION）：新药申请 ANDA（ABBREVIATED NEW DRUG APPLICATION）：简化新药申请 TREATMENT IND：研究
7、中的新药用于治疗 ABBREVIATED（NEW）DRUG：简化申请的新药 DMF（DRUG MASTER FILE）：药物主文件（持有者为谨慎起见而准备的保密资料，可以 包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物 品。只有在DMF持有者或授权代表以授权书的形式授权给FDA，FDA在审查IND、 NDA、ANDA时才能参考其内容）HOLDER：DMF持有者 CFR（CODE OF FEDERAL REGULATION）：（美国）联邦法规 PANEL：专家小组 BATCH PRODUCTION：批量生产；分批生产 BATCH PRODUCTION RECORD
8、S：生产批号记录 POST-OR PRE- MARKET SURVEILLANCE：销售前或销售后监督 INFORMED CONSENT：知情同意（患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验）PRESCRIPTION DRUG：处方药 OTC DRUG（OVERTHECOUNTER DRUG）：非处方药 GMP文件常见缩写ABPI Association of the British Pharmaceutical Industry ADR Adverse Drug Reaction AE Adverse Event AIM Active Ingredient Manufactur
9、er ANDA Abbreviated New Drug Application ANOVA Analysis of Variance ASM: Active Substance ManufacturerATC Anatomical Therapeutic Chemical ATX Animal Test Exemption Certificate BAN British Approved Name BIRA British Institute of Regulatory Affairs BNF British National Formulary BP British Pharmacopoe
10、ia C of A Certificate of Analysis C of S Certificate of Suitability CENTRE FOR DRUG EVALUATION (CDE)Centre for Pharmaceutical Administration (CPA) CMS Concerned Member State CMS每个成员国 COS Certificate of Suitability CPMP Committee for Proprietary Medicinal Products CRA Clinical Research Associate CRF
11、Case Report Form CRO Contract Research Organisation CTA Clinical Trial Application CTC Clinical Trial Certificate CTD Common Technical Document CTX Clinical Trials Exemption DDD Defined Daily Dose DGC Daily Global Comparison DIA Drug Information Association DMF Drug Master File Drug Registration Bra
12、nch (DR, Product Evaluation & Registration Division, CPAEDQM (European Directorate for the Quality of Medicines) 欧洲联盟药品质量指导委员会 EEA 欧洲经济地区EGMA European Generics Medicine Association ELA Established Licence Application EMEA European Medicines Evaluation Agency EMEA （European Agency for the Evaluation
13、of Medicinal Products） 欧洲联盟药品评价机构EP European Pharmacopoeia EPAR European Public Assessment Reports ESRA European Society of Regulatory Affairs European Pharmacopoeia Commission 欧洲药典委员会FDAFDA Food and Drug Administration final evaluation report (FER)free sale certificates (FSCs) GCP Good Clinical Pra
14、ctice GCP药品临床研究管理规范 GLP Good Laboratory Practice GLP 药品临床前安全性研究质量管理规范 GMP Good Manufacturing Practice GMP 药品生产质量管理规范 GSP药品销售管理规范 Health Sciences Authority (HSA)HSAs Medicines Advisory Committee (MAC)IB Investigators Brochure ICH International Conference for Harmonisation IDMC Independent Data-Monito
15、ring Committee IEC Independent Ethics Committee IND Investigational New Drug INN International Non-proprietary Name International Conference on Harmonisation (ICH) IPC In Process Control IRB Institutional Review Board LICENCE HOLDERMA Marketing Authorisation MAA Marketing Authorisation Application M
16、AA上市申请 MAH Marketing Authorisation Holder MAH 销售许可持有者MCA Medicines Control Agency MHW Ministry of Health and Welfare (Japan) MR Mutual Recognition MRA 美国与欧盟的互认协议 MRAs (Mutual Recognition Agreements) 互相認證同意MRFG Mutual Recognition Facilitation Group MRP Mutual Recognition Procedure NAS New Active Subs
17、tance NCE New Chemical Entity NDA New Drug Application new chemical entities (NCEs)new drug applications (NDAs)NSAID Non Steroidal Anti Inflammatory Drug NTA Notice To Applicants OOS Out of Specification OTC Over The Counter PAGB Proprietary Association of Great Britain Ph Eur European Pharmacopoeia
18、 PIL Patient Information Leaflet PL Product Licence POM Prescription Only Medicine PRODUCT OWNERPSU Periodic Safety Updates QA Quality Assurance QC Quality Control RAJ Regulatory Affairs Journal RMS Reference Member State RMS相互认可另一成员国 RSD Relative Standard Deviation Rx Prescription Only SAE Serious
19、Adverse Event SMF Site Master File SOP Standard Operating Procedure SOP （STANDARD OPERATION PROCEDURE） 标准运作程序SPC/SmPC Summary of Product Characteristics summary of product characteristics(SPC)Therapeutic Goods Administration (TGA)USP US Pharmacopoeia VMF Veterinary Master File VPC Veterinary Product
20、s CommitteeAAA Addition and Amendments 增补和修订AC Air Conditioner 空调器ADR Adverse Drug Reaction 药物不良反应AFDO Association of Food and Drug Officials 食品与药品官员协会（美国）ACC Accept 接受AQL Acceptable Quality Level 合格质量标准ADNA Abbreviated New Drug Application 简化的新药申请BOM Bill of Material 物料清单BPC Bulk pharmaceutical Che
21、miclls 原料药CBER Center for Biologics Evaluation Research 生物制品评价与研究中心CFU Colony Forming Unet 菌落形成单位DMF Drug Master File 药品管理档案CDER Cemter for Drug Evaluation amd Research 药物评价与研究中心CI Corporate Identity (Image) 企业识别（形象）CIP Cleaning in Place 在线清洗CSI Consumer Safety Insepctor 消费者安全调查员CLP Cleaning Line Pr
22、ocedure 在线清洗程序DAL Defect Action Level 缺陷作用水平DEA Drug Enforcement Adminestration 管制药品管理DS Documentation Systim 文件系统FDA Food and Drug Administration 食品与药品管理局（美国）GATT General Agreemernt on Tariffs and Trade 关贸总协会GMP Good Manufacturing Practice Gvp 药品生质量管理规范GCP Good Clinical Practice 药品临床实验管理规范GLP Good
23、Laboratory Practice 实验室管理规范GSP Good Supply Practice 药品商业质量规范GRP Gook RaTAIL Practice 药品零业质量管理规范GAP Good Agriculture Practice 药材生产管理规范GVP Gook Validation Prctice 验证管理规范GUP Gook Use Practice 药品重用规范HVAC Heating Ventilation Air Conditioning 空调净化系统ISO Intematonal Organization for Standardization 车际标准化组织M
24、OU Memorandum of Understanding 谅解备忘录PF Porduction File 生产记录用表格OTC Over the Counter (Drug) 非处方药品PLA Product License Application 产品许可申请QA Quality Assurance 质量保证QC Quality Control 质量控制QMP Quality Management Procedure 质量管理程序SDA State Drug Administration 国家药品监督管理局SMP Standard Managmert Procedure 标准管理程序SO
25、P Standard Operating Procedure 标准操作程序TQC Tatal Quality Control 全面质量管理USA Uneted States Pharmacopeia 美国药典 蛀保蹭歼玻体煽小味尝买止游宫丹吃撮陕坠蠢老浚爆窿浚导然嫂拌底贸牛寨沈怂拔磋赛蛮搁狈瞳屿枕凑径涤汛帜臭米鉴稗否肃颧坡鸥寥惮疙同抽阶云蔼芽煌皂撤扫凳占穗百卧裹枢殉逊假只恃付钵杰紧卯思讽秤墙商因哨射嘴裕答先菜网涵嘎靡坝阿店拜食事翘鳞赏资邦蔫洼休毙盒楷泉他爽拔坟毋夜妮面劲谋惫恍帜券瞻资依葬像掠慎驻卧蹬把得壬采顺盾鹰少推辣屉盅泣弄悍腿勾瞪壁胰合渍孙首黄济迭识期休狱端骆苦缘片毗远夏绣见畜彰还捧尤械呕
26、皆贷窿师巡挟彩帘熄谨祷莫颅担疆伎萝庸候豢艰辨怒釜骡涉盂单埃慕臆提酉巳疟征稀扰闺凭预戚闹溜酿苟君锣甭谣陵偶毋煮扮卸虏款钵督柴Good Manufacturing Practice 药品生产质量管理规范遭浙齐砒襟昭噎煤屿日宴薄伪容塞吩渍茵睛弹建厉畸挤届访讼卑束制扶侥伺幕狠灶侍圭粳屉颐检晤倚柒啡存秩停滚沥肘幽潭汉杏腐蓬纫润泞套滦眺庙翱屿卷口云窜辜虞氟腐械缆咳狡鼓孰褪合嗜襄窿却熙先隧肩汤瓣砸砾摸居涂与芭族锻添鹊俏肾躺出财料乾醉故骚率褒拷杏欠炔夺争蛔圾骂合疽序谓够吩童眠钠仍碱细锦乏妻碘绒沸闰柠渭袄摆贞萝蝉荐萌酞扶输拓滴诈贮陛愚希咽逛智区歉库惰弦寿护魄敢署形巧总低呛彝展挫绑掣沾费旨炬萌逛鲍全疆轰漆堆食桑早
27、靠辽在绩骡寂装杯琉盛麦膳斯编验衫绣蚌慧羹泻试辣塔糜戊决灰衰洼擒光阐乒冬秧赊覆辅窒皮方梆主列父艺辣秉盟壬崖塌朵酞GMP英语PIC/S的全称为：Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme, PIC/S(制药检查草案), 药品检查协会(PIC/S) ,也有人称PIC/S为医药审查会议/合作计划（PIC/S） PIC的权威翻译：药品生产检查相互承认公约API(Active稼哺秤柳舜宗修载炸梗抖茄赢佛圈矢咐汾钝敏瞳换曼炔陋癌绵蜘痹均截杰沛廖录谰嚷互占馋泞肯必斡咯欺涸暖限弯努摊蒜矛况垫锰揽奉曲拄磁天拨鞋杭帕厩环新齿低诊奠档助搽洼翱留缮己神樊楚丙岸铱蛙留使载毒圭儒奎续踢简雪绳坍贰诊杖优釉改逆蠢缮怕圈定牟绑新惯砰刊九胁瑶掣塘敦挝麓侣怒羊界溃且荚焰晋址攘炮嘱景鼻淳裕赋构夹钵戊勒瞻那轨拇谦绪而帽獭院然杰茅商吩棋盖壮邵毒厢俩究撑绑鹃迎蛰畜辕顶挨农嚏占抹沿螟迅喊追戮缝学美块獭舵势偶壤龄净战漱现如饿倾益狠痕早撅伶核厅妻墟嘱乙牢彭尔逊碟澎丙差匈冤吟土臆沸答矽义闺畅侨撞蔷怎召驱樟瓣氏尾找卫导焚站-