AN ANALYSIS OF FDA FY2018 DRUG GMP WARNING LETTERS

AN ANALYSIS OF FDA FY2018 DRUG GMP WARNING LETTERS

This article presents a detailed summary of the drug GMP warning letters issued in FY2018, as well as a comparison of trends since fiscal year 2013. A comprehensive GMP intelligence program includes evaluation of health authority enforcement actions, including FDA Forms 483, warning letters, seizures, recalls, and consent decree agreements. This allows manufacturers and sponsors to identify new trends in the focus of FDA inspectors and to act to address or justify similar situations at their own firms. Section 4.2 of ICH Q10, Pharmaceutical Quality System, specifies the “Monitoring of Internal and External Factors Impacting the Pharmaceutical Quality System,” including “Emerging regulations, guidance, and quality issues…”. Enforcement actions should be monitored as a component of quality issues mentioned in the Q10 guidance. Although the FDA is more transparent regarding enforcement actions than other health authorities, readers are encouraged to follow information published by Health Canada (Drug & Health Product Inspections and Inspection Tracker), Eudra GMDP reports of noncompliance, and WHO Notices of Concern.

For detail reading, explore the link:

https://www.pharmaceuticalonline.com/doc/an-analysis-of-fda-fy-drug-gmp-warning-letters-0003

Published By: Dr. Tarun Chugh