20/21 September 2022
The new USP general chapters <665> and <1665> have been finally approved. According to the USP, chapter <665> Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products establishes a baseline for the qualification of plastic components used in the manufacturing of pharmaceutical and biopharmaceutical drugs. USP General Chapter <665> is currently anticipated to become official on May 1, 2022. However, the chapter is informational only and not compendially applicable unless otherwise specified by regulators and enforcement bodies.
USP General Notices 3.10, Applicability of Standards states that a chapter below <1000> does not become an applicable general chapter unless referenced as such in General Notices, a monograph, or another applicable general chapter numbered below <1000>. None of these situations currently applies to <665>, therefore it is currently not an applicable general chapter.
To address inquiries and to give USP more time to engage with stakeholders regarding the suitability of making <665> an applicable general chapter and track the ICH Q3E Guideline for Extractables and Leachables (E&Ls) development, the USP General Chapters–Packaging and Distribution Expert Committee intends to revise <665> in order to extend the official date for <665> to May 1, 2026. It is expected that the revision will be posted as a Revision Bulletin on April 25, 2022.
More information is available in USP´s Notice of Intent to Revise <665> Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products.