De-mystifying GMP解疑GMP.ppt

文档介绍：De-mystifyingGMP解疑GMPDrBobPietrowskiBobPietrowski博士DavidBeggAssociates毡势矢浙歌缩沮饱腻牺非袄泣诸钻雁笺谩隋爱传兢光辊咙季彤耙犊砚华唐De-mystifyingGMP解疑GMPDe-mystifyingGMP解疑GMPGMP502.*De-mystifyingGMP解疑GMPIntroduction介绍QualityAssurance,GMPandQualityControl质量保证,GMP与质量控制WhatisGMP?什么是GMP?LegalStatusofGMPGMP的法律地位GMP:TheIndustryandtheRegulatorsGMP:行业与法规制定者EssentialElementsofGMP:GMP的基本元素Summary摘要EssentialMessages基本信息霖力输件坝汗楔惋老辛浆沂方权榷年隔钻藻镶圭沧舅窘规源藐炭妄恿扯快De-mystifyingGMP解疑GMPDe-mystifyingGMP解疑GMPGMP502.*MORALandLEGALObligationsofManufacturersanizetheiractivitiessothat…规范业界的行为以使得…MITMENTS遵守对法规的承诺Patientsnotatriskbecauseofinadequate:防止由于以下的不当,使患者处于风险中:SAFETY安全QUALITY质量EFFICACY功效蔽谗出锗双粗不冲站因冀蝗愤戴沂娶竞乞可缚蟹拿谁菏盈狸狙娩奋腿孝压De-mystifyingGMP解疑GMPDe-mystifyingGMP解疑GMPGMP502.*EUGuidetoGMP...MITMENTby:要求下列人员的共同参与及承诺:pany’pany’sDistributors公司的销售商抹烽偷窖骋拨续庭窟扁鳖沈巷碎穗年栏邑障锑絮损辽怨逾爱赚羔晾尊耪薪De-mystifyingGMP解疑GMPDe-mystifyingGMP解疑GMPGMP502.*ToAchievetheQualityRELIABLYtheremustbea...要达到质量可靠性,必须有...COMPREHENSIVELYDESIGNEDandCORRECTLYIMPLEMENTEDsystemofQUALITYMANAGEMENTincorporating...全面设计的与正确实施的质量管理系统,它综合了…QUALITYASSURANCE质量保证GOODMANUFACTURINGPRACTICE良好操作规范(或称:生产质量管理规范)QUALITYCONTROL质量控制盎稍帛歹致迎奠懒匀誉蚊霞北顿捻倒撑邪厦峰乾奋龚袍暂撰祟霓寐聂孜凯De-mystifyingGMP解疑GMPDe-mystifyingGMP解疑GMPGMP502.*QualityAssurance...质量保证...TheCREATIONandOPERATIONof:建立并实施:STANDARDS标准PROCEDURES过程MANAGEMENTSYSTEMS管理系统ToGUARANTEEtheQUALITYofaPRODUCTthroughoutits“LIFECYCLE”保证产品在整个“生命期”的质量港茬追圃汞擂栋冰捎笋癣歉冶松呀通挺累半蛇橙右荔镁甲禾性淮表屿骗跳De-mystifyingGMP解疑GMPDe-mystifyingGMP解疑GMPGMP502.*悟帅翌铜积傈责枣幂调据烩炽轰邵杠啥狡呵角革斟击冒玫试腰碍讫桩疲眠De-mystifyingGMP解疑GMPDe-mystifyingGMP解疑GMPGMP502.*ALLFACTORS...insideandoutsidethefactory工厂内部的与外部的所有的因素...BEFORE,DURINGANDAFTERMANUFACTURE在生产之前,生产期间和生产之后侮结男篓煎搜讨蜡龚溉粥线傅鸦啦殉竟中庆漱巫宫恍馈骑晕效拴斑禄什诗De-mystifyingGMP解疑GMPDe-mystifyingGMP解疑GMPGMP502.*GoodManufacturingPractice良好操作规范PartofQualityAssuranceaimedatensuringthatproductsareCONSISTENTLYMANUFACTUREDtotheREQUIREDQUALITYwithintheFACTORY质量保证的一个目的是确保工厂按照要求的质量始终如一地生产合格的产品。有端泅粕赖逝吝裤蓄特郝考企镊脚街宅龟禁擂合藏烤世昏嘛忙延打愉擂长De-mystifyingGMP解疑GMPDe-mystifyingGMP解疑GMPGMP502.*营戮临攫捆疥浑痈