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.
Jeanne Moldenhauer
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Jeanne Moldenhauer is Vice President of Excellent Pharma Consulting, Inc. 404 Washington Blvd, Mundelein, IL 60060 (USA). jeannemoldenhauer@yahoo.com
Tel. +1 847 837 8191
Articles by Jeanne Moldenhauer
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.
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Latest Updated Articles
- Review of FDA Warning Letters
Published: April 1st 2011 | Updated:
- Passing Cleanroom Inspections
Published: November 30th 2010 | Updated:
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