The focus of this book is to provide a way to prepare for a FDA inspection of an aseptic facility by reviewing Warning Letters recently issued to pharmaceutical companies. The number of Warning Letters issued by FDA has been rising in recent years. The FDA publishes Warning Letters in its Electronic Reading Room available on its website (www.fda.gov). The problem is that it takes time to download and review the documents and look at them cohesively for their impact on your operation. This book has taken these observations and segregated them according to the applicable GMP requirements,
making them easier to look at in a systematic fashion.
Based upon lengthy industry experience, Jeanne Moldenhauer has done the work for you by reviewing all relevant recent Warning Letters for aseptic processing topics and has identified areas of focus and interest for investigators, some of the types of issues deemed important by the investigator, and potential issues that may be applicable at an aseptic processing site.
This invaluable guide is a must read for all personnel involved in any way with the pharmaceutical aseptic processing inspection process.
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Book wrote in April 2010
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Table of Contents:
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2. Why Can FDA Inspect My Plant?
3. FDA`s Approach to
4. A Review of Recent Warning Letters: Aseptic
About the Author
Jeanne Moldenhauer, Excellent Pharma Consulting, has nearly 30 years of
experience in the pharmaceutical industry. She chairs the PDA Environmental Monitoring/Microbiology Interest Group, serves on the PDA Scientific Advisory Board, founded the Rapid Microbiology User`s Group TM, and is a member of ASQ
and RAPS. She is the author of Recent Warning Letters Review for Preparation of a Non-Sterile Processing Inspection,
Volume 2; Recent Warning Letters Review for Preparation of an Aseptic Processing Inspection and the Editor of Steam
Sterilization: A Practitioner`s Guide; Laboratory Validation: A Practitioner`s Guide; Systems Based Inspections for Pharmaceutical Manufacturers and Thermal Validation in Moist Heat Sterilization among numerous other recent
publications. She is the winner of the 2010 and 2005 PDA/DHI Distinguished