Drug GMP “Surveillance” Will Link Compliance Information To Inspections
This article was originally published in The Tan Sheet
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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Batch failure and other measures commonly tracked by manufacturers could be aggregated into an industry-wide index that FDA would use to help make risk-based inspection decisions.
OGD Director Geba says generic manufacturers still suffer from extensive quality problems, but GPhA officials argue the industry is doing fine and communications with the agency need to be more uniform.
FDA could help create several international coalitions to carry out the agency’s globalization plan, which could allow for issue-specific groups focused on individual pharmaceutical sectors.