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

"What, You Call That A RABS?" 7 (Real-Life) Aseptic Filling Blunders To Avoid

"What, You Call That A RABS?" 7 (Real-Life) Aseptic Filling Blunders To Avoid

Restricted-access barrier systems (RABS) have been a major part of pharmaceutical aseptic filling operations for many years. They were introduced around the year 2000, and by 2007 there were 75 installations in the business globally.1 Today, there may be several hundreds, most of which are in GMP-compliant facilities and serving the needs of the business. RABS were born out of the need to: 1) protect the operators from the products they were filling, 2) improve filling compliance, 3) provide better access to a wider variety of filling process equipment, and 4) bring legacy lines into better compliance. This last point is critical for CMOs because their batch sizes vary widely, necessitating frequent and rapid changeovers, as well as addressing the variations in vial sizes and filling setup parameters.

There are many excellent and scholarly articles written about RABS and RABS vs. isolators; however, this is not a technical article. This article is based upon our travels over the last 10 years, looking at aseptic filling operations and seeing what was described to be “a RABS” by the various owners. These RABS are all dubious devices created by their owners, who are deluding themselves into believing they have a validated aseptic RABS. Some of these are actually amusing, and they illustrate what happens when “hands-on” engineering meets the needs of operations while the compliance department is asleep at the wheel.

For detail reading, follow the link:

https://www.pharmaceuticalonline.com/doc/what-you-call-that-a-rabs-real-life-aseptic-filling-blunders-to-avoid-0001

Published By: Dr. Tarun Chugh