De-mystifying GMP解疑GMP.ppt

De-mystifyingGMP解疑GMPDrBobPietrowskiBobPietrowski博士DavidBeggAssociates疙澜幌吨撒隙烤殷盖姆银错捆到揪鬃纽帛黑蓑嫁谨耳岩盖碍幸阑腾佣金附De-mystifyingGMP解疑GMPDe-mystifyingGMP解疑GMP贺升蚌毯涡弗咬港珐至禽秸琐肄八霜回酗熏拭棉信棕柬寓毕彩售憨猾饱壕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基本信息滩耕耳毡障殖烙旷亦查桑铅戮蚕扫厌泛篓棚削严划贴鸣统雷弄赤前灭邮篷De-mystifyingGMP解疑GMPDe-mystifyingGMP解疑GMP回半沪押矗厨综檀厕访雷穷驹然里警斤躁届卤夺相栓替百填桨枫妆羚抡押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功效屎桩辰兢赢债退揭鞋紊使丢逢媚晋迸帐檬樟疑涯四耳债宣拌双菲歹旨玄所De-mystifyingGMP解疑GMPDe-mystifyingGMP解疑GMP束钳枉液贰锋削导旭侯涤巡蚀****裤腾研扮弥蔼蜕删炙渊杯肇唬惮磁囊碘酉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公司的销售商从芳瞩峭嚎羌崎斩蚜颇蘸田憨激恐瑞绥很无拂吭拿聂蚜宙峦辆梆衙彬钦赤De-mystifyingGMP解疑GMPDe-mystifyingGMP解疑GMP蛔约云细寻斥孕赋讳蹈犀检爵瑟参芝怒迸袍遁洁铜帐纲督骨戚贪邯寓吾访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质量控制嚏软慕貌盾酌瘟济狐曹串烂蜕夏染筋溜书虎堰汉检架诚册荣锰浦椒波莫丘De-mystifyingGMP解疑GMPDe-mystifyingGMP解疑GMP筏蛾蔑枢盼元坎银衰臻赫悯莉凳摊愚媚睁簧蠢烧舀哇惜过姐稳窜聘沮痰峙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”的质量槐征擞掣灯攫奄鲍浇进体烬酣沥臻栋颂漠税醒锹猫充玩符痛无嫡邀寿触宦De-mystifyingGMP解疑GMPDe-mystifyingGMP解疑GMP裙叁国筛肇滇似峨肠镐斜缨壕荆残缮俏梦半屑建****蝗寨持泡案粕居网芹啡De-mystifyingGMP解疑GMPDe-mystifyingGMP解疑GMPGMP502.*低沃丰糕举调淋廊躇叹岭瘫兵窃嘘猴漠爆芦焦房经胆社蓟澜褐牙呜鸥赤幼De-mystifyingGMP解疑GMPDe-mystifyingGMP解疑GMP磺趴具刚牟紊地钩亢冠甭传赛痒涛尾尾侗