We are pleased to invite you to our next webinar focused on USP General Chapter <665> in partnership with Desmond Hunt from US Pharmacopoeia on May 12 at 3 PM CEST.
Understanding the expectations set by USP is becoming increasingly important for anyone involved in the selection and qualification of plastic components used in pharmaceutical manufacturing. This webinar will outline the scientific principles, regulatory context, and practical tools that support a risk-based approach to component qualification.
Main Topic Highlights:
- An overview of USP General Chapter <665>, and its relevance to pharmaceutical manufacturing components
- The science and risk-based framework used to qualify plastic components and systems
- The tiered approach, including initial assessment, risk evaluation, and chemical characterization
- The risk evaluation matrix and how risk levels drive testing expectations
- Standardized extraction conditions, including temperature, duration, surface area-to-volume ratio, and dynamic extraction
- Status updates, expert panel activities, and alignment with ICH Q3E