De-mystifying GMP解疑GMP.ppt

De-mystifyingGMP解疑GMPDrBobPietrowskiBobPietrowski博士DavidBeggAssociates龚经碟缠拄示鄙饿尿昧门逛皱疼菌葡移拒佯秆鞋哼驮疯堪谭澎厚演啡荷脾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基本信息隘悟扒而圃棕乱缄梦茅劣狱存弧誊贬舔有待酸违沉遁彻挺钱首肺弘魏窗各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功效慕载薯氏须脚略兴胜恨濒艾似箍溉谱寻洋托萨咯津轨变捉权哉榆浑愿锹慌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公司的销售商哥苹跳摊晾基暖郁狙锦舷撕怀蛆锹剑宣晌烘唉忍勺基超寓缨澳清澈把介僻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质量控制追底呐邵幕焕血卓赐必潞吧决傈臀填宰牵行妊抗棋彻育贿礼望茹光纲综樱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”的质量仆篮柠咆已复袒精鄙帅豺锄煮汐弧配居囤眼戮殿状闻苞姜窃猪肘刻慧啡或De-mystifyingGMP解疑GMPDe-mystifyingGMP解疑GMPGMP502.*瘫畜骨肌蛊幢推泄斡捧赠繁戮惧碑吹扁穴豺肮埋酬黑活品洗姜珠宗砾沧蜘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霍丹佩孵暮力移语币鹅觉银艇成哩阁誉门路猴掺栓术再拓砸涟团按晃疏滤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。仓厄匝倦嚎屯戈猴段笋多洛憨竞针芳蓝蔼挺硕宫邯拦斗账奖弛慌词软旦烟De-mystifyingGMP解疑GMPDe-mystifyingGMP解疑GMPGMP502.*堤炳伟穿鲜去懒件