USP general chapters <665> and <1665> have been officially approved in 2022. To allow time for implementation, the USP General Chapters – Packaging and Distribution Expert Committee has extended the official effective date to May 1, 2026. Although this deadline seems to be far the time to prepare is now.
USP <665> and <1665> guidance for single-use technology are expected to become key documents related to the qualification of plastic components and systems used to manufacture pharmaceutical drug products and biopharmaceutical drug substances and products.
Potential leachables are one of the main concern in components qualification and only an effective risk-based strategy ensures that all the components belonging to a specific manufacturing process are evaluated for their regulatory compliance and potential interaction with the process stream.
The risk assessment approach enables the end user to prioritize the items to be tested. USP also provides guidance to select the most appropriate analytical approach and how to evaluate the data generated.
During this webinar, our Regulatory Consultant and Senior Scientific Director, will provide a clear overview of USP <665> to help clients to understand how E&L can be most effectively managed through timely and meticulous evaluation for a successful transition.
Details of the standard assessment and testing approach for qualification of plastic components and systems used in drug manufacturing will be discussed.
Thanks to our outstanding analytical and toxicology assessment experience on E&L, across the largest panel of products, we will provide insights to help clients avoid product withdraw from the market.