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Understanding and Implementing USP <665> for Single-Use Systems
USP <665> provides a thorough explanation of the potential E&L complications from implementing single-use components in a manufacturing process as follows. Mandatory compliance with USP Chapter <665> is expected as it will become official on May 01, 2026. It is imperative for manufacturers to begin preparing now to ensure full compliance and avoid any disruptions when the new standards come into effect.
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USP <665>
Everything you must know about plastic components and systems used in the manufacture of pharmaceutical drug products.
Risk Assessment
How to implement a systematic evaluation of the potential risks associated with E&L from single-use systems (SUS).
Getting Ready
A guide to prepare for USP <665> compliance smoothly and in time.