Cleanroom regulatory trends: A review of FDA warning letters

Cleanrooms remain a central focus of regulatory inspections and it is good practice for those working within pharmaceuticals and healthcare to assess regulatory trends. This task is difficult within Europe, where only broad overviews are released (due to data privacy restrictions) and it becomes complex when assessing output from U.S. FDA, given the hundreds of warning letters issued. To assist with this process, this article assesses recent FDA warning letters and draws out the main trends and significant non-compliances relating to cleanroom design, testing and operations.

Tim Sandle has written a new article:

Sandle, T. (2019) Cleanroom regulatory trends: A review of FDA warning letters, Clean Air and Containment Review, Issue 38, pp20-24

For details, please contact Tim Sandle

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology