How to Get Ready for New General USP Chapters <665> and <1665>

Join our webinar to gain an introduction to the new USP chapters addressing the risks of E&L.

Overview

2023 saw the long awaited adoption of the new general USP chapters <665> and <1665>, which address the risks of extractables and leachables in plastic components and systems used in the manufacture of pharmaceutical products.

USP is mandatory and comes into full effect on May 1, 2026. Although the time left is short, there is still enough time to implement its regulatory measures.

Objective

This webinar provides an introduction to USPs and includes a case study demonstrating their use in real life. You will have the opportunity to network with SGS experts, who will answer your questions on the topic.

Agenda

• USP – characterization and qualification of plastic components and systems used to manufacture pharmaceutical drug products and biopharmaceutical drug substances and products
• USP – plastic components and systems used to manufacture pharmaceutical drug products and biopharmaceutical drug substances and products
• Risks associated with process equipment-related leachables (PERLs) in upstream and downstream processes
• The use of risk levels and mitigation factors
• AET calculation and extrapolation
• Case study
• Q&A

Target Audience

This webinar is aimed at anyone who needs to qualify processes in the area of pharmaceutical production, single-use and material suppliers, buyers of SUS, QA managers and regulatory affairs managers.