FDA Inspection Findings Provide Additional Insight on CGMP Expectations for Combination Product Manufacturers

The light being shed on the current GMP regulatory expectations for risk management and manufacturing control of combination products by FDA’s inspection engagement with pharma sponsors and their device partners has been a focal point at recent conferences in the US and Europe.

Coming into relief in these conference discussions is the importance of the communication process that needs to take place among those involved in manufacturing the drug, the device components, and the finished combination product in identifying what the key risks involved are and putting in place the right control strategy to address them. Also of concern is how well information is flowing within CP sponsor companies – between departments and with senior management.

FDA investigators have been taking a hard look at this communication process as they probe into problems that have surfaced in marketed CP products. They are finding that there have been significant breakdowns around the extra layer of risks involved and controls needed in the CP context.  In focus are the knowledge management and organizational culture required to address the problems when they occur and take the right preventive action.

In turn, both US and European regulators have been highlighting these concerns in their interactions with industry at the conferences and discussing where additional industry effort should be focused to make sure that the communication gaps are filled. The regulators are also making clear that learnings are being shared among themselves in their efforts to create a better CP oversight process on both sides of the Atlantic.

Contract manufacturing and other supplier/sponsor relationships have been a strong focus of FDA compliance attention in general (see IPQ December 13, 2017). The challenges involved are only heightened by the complexities of the different GMP regulations, standards, concepts, and terminology that come into play in the CP context.

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