ISPE’s Product Quality Lifecycle Implementation (PQLI®) initiative was created to provide guidance on practical implementation of the concepts described in ICH guidelines, focusing on Q8, Q9, Q10 and the future Q11 to help ensure product quality throughout a product lifecycle, leading to continuous product improvement.
PQLI Technical Teams are working groups addressing broad cutting edge regulatory & compliance issues that affect industry across dosage forms and in small and large molecules.
PQLI® Good Practice Guides provide information on global solutions to implementation challenges of ICH guidances.
PQLI Good Practice Guides reference other case studies and relevant documents in the public domain. Many thanks must be extended to the teams which produced these documents, names and company affiliations of members of these teams being available from the documents.
For more information, contact RegulatoryAffairs@ISPE.org.