New USP Draft Chapter on Plastic Components Used in Manufacturing

Recommendation

15/16 November 2023

Serialization/Aggregation - Live Online Training
Requirements, Challenges & Solutions

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:

• <665> Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products
• <1665> Characterization of Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products

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.

Changes to the previous proposals

Previous proposals for these two new USP chapters were published with the following titles

• Polymeric Components and Systems Used in the Manufacturing of Pharmaceutical and Biopharmaceutical Drug Products <665> in PF 43(3) and Plastic Materials, Components, and Systems Used in the Manufacturing of Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products in PF 45(2),
• Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products <1665> in PF 43(3) and Characterization of Plastic Materials, Components, and Systems Used in the Manufacturing of Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products in PF 45(2). 

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>:

• Clarify the scope,
• Decouple chapter <665> from general chapter <661.1> Plastic Materials of Construction and focus the current proposal on manufacturing components (Chapter <665> was initially published as Plastic Components and Systems Used in Pharmaceutical Manufacturing <661.3> in PF 42(3)),
• Clarify the component qualification versus selection as the chapter's focus,
• Delineate the hierarchical relationship between component and materials testing,
• Provide for flexibility regarding the design of the risk evaluation matrix,
• Revise the risk-based chemical and biological reactivity testing requirements for components.

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.