GoodManufacturingPractice药品生产质量管理规范

1、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：药品生产检杏相互承认公约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；ba

2、tch numbering system 批次编码系统；batch records 批记录；bulk product 待包装品；calibration 校正;clean area 洁净区; consignmccnt (delivery)托销药品。fda (food and drug administration )：(美国)食品费品管理局ind (investigationalnew drug)：临床研究申请(指申报阶段湘对于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 (abbrevia

3、ted new drug application)：简化新药申请treatment ind：研究中的新药用于治疗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卩的形式授权给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

4、batch production：批量生产；分批生产batch production records：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示表示同意接受 治疗或试验)prescription drug：处方药otc drug (over-the-counter drug)：非处方药gmp文件常见缩写abpi association of the british pharmaceutical industryadr adverse drug reactionae

5、 adverse eventaim active ingredient manufactureranda abbreviated new drug applicationanova analysis of varianceasm: active substance manufactureratc anatomical therapeutic chemicalatx animal test exemption certificateban british approved namebira british institute of regulatory affairsbnf british na

6、tional formularybp british pharmacopoeiac of a certificate of analysisc of s certificate of suitabilitycentre for drug evaluation (cde)centre for pharmaceutical administration (cpa)cms concerned member statecms每个成员国cos certificate of suitabilitycpmp committee for proprietary medicinal productscra cl

7、inical research associatecrf case report formcro contract research organisationcta clinical trial applicationctc clinical trial certificatectd common technical documentctx clinical trials exemptionddd defined daily dosedgc daily global comparisondia drug information associationdmf drug master filedr

8、ug registration branch (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 associationela established lice nee applicationemea european medicines evaluation agencyemea (european agency f

9、or the evaluation of medicinal products)欧洲联盟药品评价机构ep european pharmacopoeiaepar european public assessment reportsesra european society of regulatory affairseuropean pharmacopoeia commission 欧洲药典委员会fdafda food and drug administration final evaluation report (fer) free sale certificates (fscs)gcp goo

10、d clinical practicegcp药品临床研究管理规范glp good laboratory practiceglp药品临床前安全性研究质量管理规范gmp good manufacturing practicegmp药品生产质虽管理规范gsp药品销售管理规范health sciences authority (hsa)hsa's medicines advisory committee (mac)ib investigators brochureich international conference for harmonisationidmc independent dat

11、a-monitoring committeeiec independent ethics committeeind investigational new druginn international non-proprietary nameinternational conference on harmonisation (ich)ipc in process controlirb institutional review boardlicence holderma marketing authorisationmaa marketing authorisation applicationma

12、a上市申请mah marketing authorisation holdermah销售许可持有者mca medicines control agencymhw ministry of health and welfare (japan)mr mutual recognitionmra美国与欧盟的互认协议mras (mutual recognition agreemen 互相認證同意mrfg mutual recognition facilitation groupmrp mutual recognition procedurenas new active substancence new c

13、hemical entitynda new drug applicationnew chemical entities (nces)new drug applications (ndas)nsaid non steroidal anti inflammatory drugnta notice to applicantsoos out of specificationotc over the counterpagb proprietary association of great britainph eur european pharmacopoeiapil patient informatio

14、n leafletpl product licencepom prescription only medicineproduct ownerpsu periodic safety updatesqa quality assuranceqc quality controlraj regulatory affairs journalrms reference member staterms相互认可另一成员国rsd relative standard deviationrx prescription onlysae serious adverse eventsmf site master files

15、op standard operating proceduresop (standard operation procedure) 标准运作程序spc/smpc summary of product characteristics summary of product charactcristics(spc) therapeutic goods administration (tga) usp us pharmacopoeia vmf veterinary master file vpc veterinary products committeea. a. a addition and ame

16、ndments 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 简化的新药屮请bom bill of material 物料清单bpc bulk pharmaceutical chemiclls 原料药cber center for biol

17、ogies 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 药物评价与研究屮心 ci corporate identity (image)企业识别(形象)cip cleaning in place 在线清洗csi consumer safety insepctor 消费者女全调杏员clp cleaning line procedure 在线清洗程序dal defect actio

18、n 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 agrccmcmt on tariffs and trade 关贸总协会gmp good manufacturing practice gvp 药品生质量筲理规范gcp good clinical practice约品临床实验管理规范glp good laboratory practice 实验室管理规范gsp good supply practice药晶商业质量规范grp gook ratail practice药品零业质量竹理规范g