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
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