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Consumer BioPharmaceutical Middle East and Africa

Drug GMP “Surveillance” Will Link Compliance Information To Inspections

This article was originally published in The Tan Sheet

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Executive Summary

CDER Director Janet Woodcock says a new database will drive risk-based inspection decisions. Once active and combined with new objective quality measurement data, the system should allow all relevant agency personnel access to the same information in the hopes of improving oversight.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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