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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
Jeanne Moldenhauer is Vice President of Excellent Pharma Consulting, Inc. 404 Washington Blvd, Mundelein, IL 60060 (USA). email@example.comTel. +1 847 837 8191
April 01, 2011
The author reviews Warning Letters issued between 2000 and mid-2010 for aseptic processing and non-sterile processing, and determines how many observations were made for each section of the GMPs.
November 30, 2010
A review of warning letters from the last 10 years relating specifically to cleanrooms has indicated several concerns with the appropriateness of cleanroom design - primarily regarding air flow and laminarity.