Product Quality Lifecycle Implementation (PQLI) - Articles and news items


Advance with IFPAC pathway to quality manufacturing

Issue 6 2014 / 23 December 2014 / IFPAC

IFPAC® is the essential meeting place for the latest developments in Process Analytical Technology (PAT) and Quality by Design (QbD) within the Pharmaceutical, Biotechnology & related industries. IFPAC is known for being a collaborative forum to exchange ideas and network through panel discussions, evening sessions, poster sessions and the exhibition. For over 25 years IFPAC has brought together industry, academia, research institutions, manufacturers/suppliers, as well as International and US Regulatory Agencies to discuss the latest trends in technologies, standards and controls…

PQLI – providing practical solutions

Issue 1 2008, Past issues / 23 January 2008 /

This article discusses ISPE’s Product Quality Lifecycle Implementation (PQLI) initiative, which is to provide practical guidance for implementation of ICH Q8, Q9 and Q10. It represents the author’s individual opinion. It should be noted that PQLI is an evolving work area and so will continue to develop beyond the position explained at the time of writing this article.


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