Review of Quality Deficiencies Found in Active Pharmaceutical Ingredient Master Files Submitted to the WHO Prequalification of Medicines Programme

Purpose. The aim of this work was to determine the number and type of active pharmaceutical ingredient (API) quality deficiencies in API Master Files (APIMFs) as submitted to the World Health Organization (WHO) Prequalification of Medicines Programme (PQP). Methods. We conducted a retrospective rev...

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Bibliographic Details
Main Authors: Isabel Ortega Diego, Antony Fake, Matthias Stahl, Lembit Rägo
Format: Article
Language:English
Published: Canadian Society for Pharmaceutical Sciences 2014-04-01
Series:Journal of Pharmacy & Pharmaceutical Sciences
Online Access:https://journals.library.ualberta.ca/jpps/index.php/JPPS/article/view/21228