ISPE Launches PQLI Initiative To Facilitate Implementation Of ICH Q8 And Q9 Guidelines
July 30th, 2007 by 
Barry - Admin BioPharmArena
ISPE, a global not-for-profit association of more than 23,000 pharmaceutical manufacturing professionals, launched a new initiative called Product Quality Lifecycle Implementation (PQLI) at its Washington Conference in early June.
In its role as a “catalyst for change” ISPE is working with regulators in the United States, Europe, and Asia-Pacific to help industry find solutions to the challenges in implementing ICH guidances. The goal of these sessions is to begin to define areas where industry will be able to provide the technical framework for the implementation of QbD in regulatory submissions.
Posted in Regulatory Affairs, Research and Development, Quality Assurance | 