Overview

2023 saw the long-awaited adoption of the new general USP chapters <665> and <1665> to address the risk of extractables and leachables (E&L) in plastic components and systems used in the manufacture of pharmaceutical products.  

USP <665> is mandatory and comes into full effect on May 1, 2026. Although the time left is short, there is still enough time to implement the USP’s regulatory measures. 

Objective

This webinar is aimed at all those who aren’t yet familiar with USPs <1665> and <665> and would like an introduction. The use of USPs <1665> and <665> is expertly explained using a case application example, so a real-life scenario is presented. You will also have the opportunity to network with SGS experts to answer your questions on the topic. 

Agenda

• Introduction
• USP <1665> – Characterization and qualification of plastic components and systems used to manufacture pharmaceutical drug products and biopharmaceutical drug substances and products
• USP <665> – Plastic components and systems used to manufacture pharmaceutical drug products and biopharmaceutical drug substances and products 
• The risk associated with process equipment-related leachables (PERLs) in upstream and downstream processes
• The use of risk levels and mitigation factors
• AET calculation and extrapolation 
• An insightful case example 
• Q&A

Target Audience: The webinar is aimed at anyone who needs to qualify processes in the area of pharmaceutical production, single-use or material suppliers, buyers of SUS and managers in QA as well as regulatory affairs.

Language: English

Can't make a live session? Register now and receive a complimentary recording after the live event. For further information, please contact: healthscience@sgs.com