6. 从WHO预认证角度的原料药质量要求--英文.pdfVIP

Requirements for demonstration of API quaqualityty froom tthee peperspectspectivee oof WHOO-PQQP Presented by Hua YIN WHOWHO PrequalificationPrequalification ProgrammeProgramme AbbreviationsAbbreviations • PQP: Prequalificaiton of Medicines Programme • API – Active Pharmaceutical Ingredient (drug substance) • FPPFPP – FiFiniishhedd PhPharmaceutiticall PProdductt ((ddrug prodductt)) • APIMF – Active Pharmaceutical Ingredient Master File (DMF) • PQ-APIs – Prequalification of Active pharmaceutical Ingredient • CEP – Certificate of Suitability (CoS) • GMP – Good Manufacturingg Practice • EDQM – European Directorate for the Quality of Medicines Quality of APIs Tutorial; 2 Hyderabad, 16  September, 2011 IntroductionIntroduction • APIAPI informationinformation forfor FPPFPP PrequalificationPrequalification (Options(Options forfor submitting API information) – API Prequalification – CEPs – APIMF procedure – Full API details in the product dossier • API-related changges after ppreqqualification of the FPP Quality of APIs Tutorial; 3 Hyderabad, 16  September, 2011 PrequalificationPrequalification activitiesactivities FPP Prequalification API Prequalification APIAPI informationinformation Quality of APIs Tutorial; 4 Hyderabad, 16  September, 2011 API Assessment Two bodies of API information are assessed during the FPP prequalifilificatitio