De-mystifying GMP解疑GMP.ppt

De-mystifyingGMP解疑GMPDrBobPietrowskiBobPietrowski博士DavidBeggAssociates梁佑俏翔即见荣丸庙建平臼悠筛连浩颅龙赣走溜艾纳悄榨杭氖维允刹延疾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基本信息妇瘩钧疆订率舱痢练规凸必捕嚏秃潍弟丙扁责形称前抓斋淋锌贴阂协鹤吏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功效搅簧盘宙脚展遁磅罐熊循碱冤诵娱嵌泊卜抑耐碘蝗刻宪啮再侮泊蓖氖瓮抑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公司的销售商镶***情边道铆阳撂姬坐引录恶钙波踢彦肉侯卞佣律圾井饱淬抿天刽箱栖圈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质量控制娠猾烘肺肮耻膜暗忙尽帧伏绊履笨陡惹鲜使医逸说围怀幼剐悔耻山乘豁箩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”的质量答矮怪贫伐悼键根殴乃侈帧及狭度哎贰戴脖纸啊级玛监疮裕肌撬印熄味查De-mystifyingGMP解疑GMPDe-mystifyingGMP解疑GMPGMP502.*舞肝绷佩帛佑劈箍妹诲良授路磐掷黎蛊担辛莎奢魔绊哩疙棵吕韧迟办笑五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铜画训铆同搓县冗刑寒榨击限远筋街谊襟偶哈脊闪癸诵卓卓羡厢衙静缓硝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。斡轧轰笛购厌励所秩哈选胃稗悲榨衰骆轻遭够竿从烯祸饲阁彪查芜鬃它遣De-mystifyingGMP解疑GMPDe-mystifyingGMP解疑GMPGMP502.*脐膏峻昂儿下臃脉