9/10 November 2021
In the current Pharmacopeial Forum, PF 46(5), revised drafts of the two previously published USP Chapters on plastic materials used in pharmaceutical manufacturing have been published:
According to the USP, the new chapter <1665> discusses the selection and qualification of plastic components and systems used to manufacture active pharmaceutical ingredients (APIs), biopharmaceutical drug substances, and biopharmaceutical and pharmaceutical drug products.
Previous proposals for these two new USP chapters were published with the following titles
On the basis of comments received (e.g. at the USP Workshop on the Revision of Chapters <665> / <1665> Plastic Materials, Components, and Systems Used in the Manufacturing of Pharmaceutical and Biopharmaceutical Drug Products, which took place on April 16, 2019), the proposals were canceled and are being replaced by the current proposals. The USP states that the following significant changes have been introduced to <665>:
According to the USP, chapter <665> would not be automatically mandatory for compendial compliance purposes. USP General Notices 3.10 emphasizes that the "Applicability of Standards, 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>". Therefore, the USP "seeks input from stakeholders regarding the advisability of making <665> an applicable general chapter, and if so, the appropriate vehicle for doing so".
The drafts can be viewed after registration for the Pharmacopeial Forum.