Majority of Drug GMP Warning Letters Mention Data Integrity, OMQ Official Says

January 8, 2016

Since January 2015, the FDA has issued 16 drug GMP warning letters covering 19 facilities, and more than three-fourths of those letters cited data integrity issues.

The letters are evenly split between API makers and finished dosage form manufacturers, with more than half going to Asian companies — a number that is heavily influenced by the API makers in the region, said Francis Godwin, director of the Division of Drug Quality II with the FDA’s Office of Manufacturing Quality.

All of the API warning letters also cited data integrity issues, and all of the companies were located outside the U.S.

Aside from data integrity, roughly one-third of the warning letters deal with sterility issues and include observations such as poor aseptic controls or contamination, Godwin said during a session of the ISPE Annual Meeting in Philadelphia.

Other sterility issues included beta lactam contamination, facilities being in disrepair, poor method validation, testing issues and poor reprocessing practices.

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