This ebook is intended to help educate readers about the importance of rapid, quality testing for extractables and leachables (E&L) to ensure cGMP compliance and, most importantly, patient safety. Inside this ebook you can learn more about trends in the biopharmaceutical market, concerns of toxic-related impurities, and recent guidance by the US FDA that can be useful in planning the proper framework to assess drug products and ensure timely delivery to market and optimization of patient health around the globe.
The contents are as follows:
- Why Extractables & Leachables Matter
- Testing of Packaging Systems for Large-Volume Parenteral Drugs: Extractables Study Design and Challenges
- Rapid Sterility Testing: A New Solution for Short Shelf-Life Products
- The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products: Some Fallacies Addressed
Learn more about the authors below.