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Review 'checklist' still desired by some firms, but AAPS/ISPE panel recommends 'no'.(CMC)
By Validation Times Staff
NORTH BETHESDA, MD -- A checklist that firms and FDA can use to determine whether a CMC submission is complete still is desired by several pharmaceutical firms, and were referenced by two separate "breakout sessions" discussing both CMC regulatory and discussion pharmaceutical development facets of FDA's new "quality assessment" system.
However, neither of the groups, which met at the AAPS/ISPE/FDA workshop here Oct. 5-7, was in favor of a checklist under the new paradigm for reviewing CMC applications.
While the pharmaceutical development (PD) group said there was "general acceptance of PD as a basis for product and process understanding and for product and process understanding and for risk management," the group said a checklist would not be recommended.
They said FDA guidance should give "whats," not "hows." But the group, headed by one FDAer, one European Union regulator and an executive at AstraZeneca, supported a "single harmonized guidance ... with emphasis on 'relevant and critical' information."
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