Transcription of «Qualification and Validation» - afphb.be
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«Qualification and Validation» - afphb.be
1 validation des Equipements et des Processus de FabricationS. Crauste-MancietAPHBP- 20 Novembre 2008 Qualification and validation Guidelines PIC/S guide to good practices for the preparation of medicinal products in healthcare establishment April 2008 PIC/S guide to good manufacturing practice for medicinal products Annex 15 qualification validation September 2007 EU Guidelines to Good Manufacturing Practice annex 1: Manufacture of sterile medicinal products March 2009 Definitions validation planning Risk assessmentQualification D finitionsPlans/Sch mas/Principes(fournisseur)Installation Termin e l arr t (client)Installation Termin een marche (Client) Installation Termin e Fonctionnelle (Client) Qualification de la conceptionDesign QualificationQualification de l installationQIQualification Op rationnelleQOQualification de PerformanceQP2 Qualification de Conception [QC] V rification des plans fournisseurs / cahier des charges utilisateur Ad quation plan / local (traitement de l ) Ad quation plan / applicationPIC/S guidelines annex 15 Design Qualificatio
1 Validation des Equipements et des Processus de Fabrication S. Crauste-Manciet APHBP- 20 Novembre 2008 «Qualification and Validation» Guidelines
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