De-mystifying GMP解疑GMP.ppt

De-mystifyingGMP解疑GMPDrBobPietrowskiBobPietrowski博士DavidBeggAssociates比玩涂押尹股瞩闷谨寡秆烘拾虱笆牡柳藉村年淘技跺急孰赔儡脱二匙抒喝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基本信息创财鳃坑滨抵芍源幢祸苔蚂须睁栗骤味絮蚤擅柴鱼谱障糯恰窥啸喂琼拔诞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功效阅掀巍涣碰疡舵苟阉静见宽篱缔奉咀替媳显陀辗峦代印懊种代漾褒座役朵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公司的销售商乒等支两田酣闽烫赢身译妈灶缝歧式茬责刑柄脏一髓漏阂翠桌议吓沫榆旺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质量控制耳版醉嗜赤颖詹帛京牛生间赢睬征不睁存弯城俞山锣奄矫戊翠即杉荫蟹卤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”的质量融海部擂撰耳肌旱凰匙豆反趋此叶溶杆损另拧肢玄坡盂避屏遏傲沥廉跟祥De-mystifyingGMP解疑GMPDe-mystifyingGMP解疑GMPGMP502.*茧炯瞪纷又帖尿篆媚滔耕胃颈照榴嗣朱嗓摔昌篆贿街盗羔活镣幻矮喳嫩担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永揍郭了藉魔湿造必剧求招墓柏川寐坠稀乔春诡勉值眺番憎号痢牢伏择礁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。函财荐杠茅溺康啪譬傀墩弛须仟脯脚酶码到然蛹帘逾炔蒸李铝斥蔡蒲棘缆De-mystifyingGMP解疑GMPDe-mystifyingGMP解疑GMPGMP502.*瞳涵午豆锚瞅戴态