Excipient Variability and its Implications with Respect to Drug Quality from a Regulator’s perspective
Posted on August 24, 2016
By: Steven Wolfgang1, Chemist
FDA
Introduction Excipient variability has become a very timely topic for scientific discussion among suppliers and users of excipients and pharmaceutical scientists2. An eye opening finding from a recent survey conducted by the Product Quality Research Institute (PQRI) on excipient variability was the ...
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Related Topics and Keywords
CAPA, CMAs, corrective and preventive action, critical material attributes, Excipient variability, FDA, IFPAC, PQRI, problematic excipient, Process Analysis and Control, Product Quality Research Institute, reengineering, reformulation, Steven Wolfgang
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