Regulatory scrutiny of extractable and leachable (E&L) submissions have increased substantially over the years and particularly over the last 5 years. The Food and Drug Administration (FDA), United States Pharmacopeia (USP), and organizations such as the Product Quality Research Institute (PQRI) have published guidance documents and best practices concerning extractable and leachable studies for the pharmaceutical industry. This webinar will discuss these guidance’s and provide insight on how to perform studies and provide the FDA submissions that meet with their expectations.
This webinar will feature a case study focused on how to use best practices for Extractable and Leachable programs, including the benefits of:
a) Starting early
b) Analytical techniques and instrumentation
c) Material science/knowledge
Key Learning Objectives
- Understand regulatory guidances that impact drug product submissions
- Best practices for a robust extractables and leachables program