Training of new employees in a pharmaceutical company almost always includes instilling a 'healthy fear' of inspections conducted by regulatory agencies. Most, if not all, countries in the world have governmental agencies responsible for the safety and efficacy of the medicines manufactured, sold, and distributed within their country. These agencies typically have the legal authority to go into the production facilities to assess the various aspects of the manufacturing and distribution facility. As such, employees learn that the company's viability is dependent upon successfully passing these inspections.The focus of this book is to describe the expectations of the US Food and Drug Administration (FDA) regarding inspections of pharmaceutical products. Specifically, it discusses a newer FDA program — the Systems-based Inspection Program.
This book is a must read for anyone involved in any way with the pharmaceutical inspection process.
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Format: PDF (1 file 3.82 MB)
Table of Contents:
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- Introduction by Jeanne Moldenhauer
- Regulatory Basis for FDA Inspections by Jeanne Moldenhauer
- Systems-Based Inspections by Jeanne Moldenhauer
- The Quality System by David A. Henninger
- The Facilities and Equipment System by Michael Millin
- The Materials System by Seth Pyers
- The Production System by Michele Conway and Robert Ferer
- The Packaging and Labeling System by Jeanne Moldenhauer
- The Laboratory System by Jeanne Moldenhauer
- Evaluating Your Facility for Compliance by Jeanne Moldenhauer
- Preparing for a FDA Systems-Based Inspection by Jeanne
- Managing of Regulatory Inspections by Jeanne Moldenhauer
- Concluding an Inspection and Handling Inspection Findings by Jeanne
About the Editor
Jeanne Moldenhauer has over 25 years of experience in sterile process validation, regulatory affairs and microbiology. She is now the Vice President of Excellent Pharma Consulting, Inc. Moldenhauer is an Interest Group Leader for Microbiology and Environmental Monitoring at PDA, Chair of the Rapid Microbiology User`s Group and a member of the Scientific Advisory Board of PDA. Moldenhauer is a published author and editor of three previous PDA-DHI books:
Environmental Monitoring: A Comprehensive Handbook, Steam Sterilization: A Practitioner's Guide, and Laboratory Validation: A Practitioner's Guide. She is the winner of the 2005 PDA/DHI Distinguished Editor/Author Award.