国际医药品稽查协约之药品优良制造规范(PICSGMP)简介

良良(PIC/S(PIC/SGMP)GMP)PartI理IPIC/SGMPGuide行GMP歷ƒ年良ƒ年cGMPƒ年行GMPƒƒ理ƒGMPƒ拓PIC/S年立PharmaceuticalInspectionConvention易立年律不若PIC/S3”了立行更流練來領立年PIC/SƒPIC/SPIC不PIC/SPICSchemeConventioninformalAformaltreatyHasnolegalstatusHaslegalstatusBetweenHealthauthoritiesBetweencountriesExchangeofinformationMutualrecognitionofinspectionsPIC/S立練流立PIC/Sƒƒƒƒ利ƒ來ƒƒ異理ƒ力ƒƒ便立理PIC/SGMPGuideƒ料Charter1理Charter2Charter3Charter4Charter5Charter6Charter7Charter8Charter9量10留199料列18料料8參數行177行(PIC/S不)166155類144133離輻122111理理QUALITYMANAGEMENTƒPRINCIPLEƒQUALITYASSURANCEQAƒ良GMPƒQUALITYCONTROLQCƒPRODUCTQUALITYREVIEW理ƒ不ƒ理不參諾理良念聯理„念念切„„良列理i.良良ii.良iii理iv.料料v.行vi.vii.行不viii.令理ix.理良„良„良兩GMP理良i.切ii.更iii.良料令iv.不令v.練行vi.錄錄切行數量錄vii.歷錄理viii.降ix.x.度理„良行行料不行不行理i.練料料良ii.料料iii.iv.錄錄切行離錄v.量度vi.錄料vii.不行viii.留料參來來異留理„切輪行料行„年行參理料料ii.iii.不切iv.切離不行v.切更vi.更vii.不良viii.切行ix.行x.更諾xi.例狀xii.QAQCGMPQA理„粒降„參練度立„度不„行料度率濾‧„不兩類類類行„理料粒降狀度„狀:例塞行連行理ƒƒƒƒ濾ƒ„¾¾„¾„¾¾粒量量行參行參PREMISESƒ滑漏ƒ理ƒ不理易理ƒ不拉理ƒ來ƒ路理理狀ƒ不流PREMISES更ƒƒ濾ƒ更理更來ƒ不更ƒƒPREMISESƒ濾流流ƒ不～ƒƒ靈ƒ錄---++++++outside---流濾流兩:STERILISATION„切都„不行„„ƒ不弄ƒ度力都ƒ錄立ƒ度ƒ力漏ƒ料ƒƒƒ濾ƒ年1.數度冷度度錄度參數行連都度冷行冷度不度不行連度參數了量年Q&AThankYouforyourattention