Article | June 20, 2022

The No. 1 Most Common Problem In FDA GMP Inspections

By Sarah Beale, MasterControl

Inspection scientist GettyImages-1180581833

COVID-19 had a dramatic impact on the inspectional activities of the U.S. Food and Drug Administration (FDA). The number of good manufacturing practices (GMP) inspections that could be completed understandably decreased and the agency found itself relying more on remote methods. While FDA oversight now looks quite different than before the pandemic, the biggest problem in FDA GMP inspections hasn't changed.

When it comes to pharmaceutical manufacturing, year after year, the same problem is at the top of the list for both FDA warning letters and Form 483s — issues involving quality responsibilities and procedures. We uncover how embracing digitization and adopting an eQMS to manage quality processes can make this problem a thing of the past.

VIEW THE ARTICLE!
Signing up provides unlimited access to:
Signing up provides unlimited access to:
  • Trend and Leadership Articles
  • Case Studies
  • Extensive Product Database
  • Premium Content
HELLO. PLEASE LOG IN. X

Not yet a member of Med Device Online? Register today.

ACCOUNT SIGN UP X
Please fill in your account details
Login Information
ACCOUNT SIGN UP

Subscriptions

Sign up for the newsletter that brings you the industry's latest news, technologies, trends and products.

You might also want to: