Dominating IPQ’s coverage during October were GMP compliance problems at both U.S. and foreign manufacturing facilities and the insight they provide on where FDA’s concerns lie and how it will respond when product quality is jeopardized.
The sponsor/contractor relationship and laboratory practices, particularly abroad, were two areas in high relief on the FDA enforcement radar screen. A $750 million settlement of a government/whistleblower suit against GSK involving GMP non-compliance at a former facility in Puerto Rico has other important lessons to offer.
Also drawing IPQ stories in October were FDA initiatives to bring more clarity and consistency around the industry/regulator dialogue on CAPA and recalls.
While there is only one CMC/review-side story in the issue this month, it is a significant one: FDA, industry and the USP have created a forum to explore how to strengthen the impurity control of OTC products to create more parity with those reviewed by CDER through the marketing application clearance process. A driver of the initiative, CDER official Scott Furness explains its significance.
In focus in Europe during the month was a revealing study by UK’s MHRA of the problems it is finding in inspecting good distribution practices.
Japan’s PMDA, Australia’s TGA and China’s SFDA are also shedding new light on their concerns about the GMP/supplier oversight that DMF holders and other manufacturers abroad should be assuming.
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