An Analysis Of FDA FY2018 Drug GMP Warning Letters

quality intelligence 1 Minute

BioProcess Online has a nice summary of the drug GMP warning letters issued in FY2018, as well as a comparison of trends since fiscal year 2013.
— Read on www.bioprocessonline.com/doc/an-analysis-of-fda-fy-drug-gmp-warning-letters-0003

Data Integrity definitely continues to be a theme, and I agree that we are seeing a growing trend around process validation. I also think root cause investigations was a theme of 2018 that we are going to be seeing a lot more of.

Published by Jeremiah Genest

Quality professional with over 20 years of experience. Gamer and storyteller with forty years of practice.

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One thought on “An Analysis Of FDA FY2018 Drug GMP Warning Letters”

  1. Pingback: 2020 FDA 483s around change – Investigations of a Dog

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