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.
ISPE launched a new industry initiative called Product Quality Lifecycle Implementation (PQLI) at its Washington Conference in early June.
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.
The first PQLI session held in Washington attracted more than 230 participants from most of the major pharmaceutical companies. The two-day session offered an exclusive opportunity for industry leaders from science, manufacturing, quality, and engineering to engage with the US Food and Drug Administration (FDA), discuss real world solutions, and help craft a pragmatic approach to implementing Q8 and Q9.
A working group will continue to monitor progress, collect information, and process into white papers, guidances, and technical documents. Teams and working groups will gather again in September in Berlin, Germany, for another working session. Additional sessions in November in Las Vegas, Nevada, USA; and Copenhagen, Denmark, in April 2008 will provide updates and opportunities for global views from within the industry to get understanding of challenges.
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