Warning Letter for Aurolife demonstrates failures in process validation

Jeremiah Genest quality intelligence December 10, 2020December 10, 2020 1 Minute

The FDA commented in a Warning Letter to Aurolife Pharma that the manufacturer lacked data showing that the process was in “state of control” before batch release. The 483 pointed to the FDA’s guidance document Process Validation: General Principles and Practices, and found the company lacks a state of control of the process, which comes back to change control.

They also found major deficiencies in their OOS and cleaning programs.

Published by Jeremiah Genest

Quality professional with over 20 years of experience. Gamer and storyteller with forty years of practice. View all posts by Jeremiah Genest

Published December 10, 2020December 10, 2020

Артём says:

February 26, 2021 at 6:25 pm

Provide a thorough, independent assessment of your overall system for investigating unknown peaks, deviations, discrepancies, out-of-specification (OOS) results, complaints, and other failures. In addition, provide a retrospective review of all distributed batches within expiry to determine if your firm released batches that did not conform to established specifications, official compendium, or appropriate manufacturing standards. FDA considers the expectations outlined in ICH Q7 when determining whether API are manufactured in conformance with CGMP. See FDA’s guidance document

LikeLike

Reply