Open Access. Powered by Scholars. Published by Universities.®
Physical Sciences and Mathematics Commons™
Open Access. Powered by Scholars. Published by Universities.®
Articles 1 - 1 of 1
Full-Text Articles in Physical Sciences and Mathematics
Overview Of The Recent Fda Process Validation Guidance For Medicinal Product Development And Manufacture, Nuala Calnan (Editor)
Overview Of The Recent Fda Process Validation Guidance For Medicinal Product Development And Manufacture, Nuala Calnan (Editor)
Conference Papers
This conference paper presents an overview of the recently published FDA Process Validation Guideline for the development and manufacture of medicinal drug products. It discusses the impacts of conducting life cycle based validation activities and highlights the future challenges in meeting the ongoing 'Continued Process Validation' (CPV) expectations of the regulator. It also presents the latest information on the EU draft Process Validation Guidance - due for publication in late 2013 / 2014.