The United States Pharmacopeia (USP) General Chapter <665> focuses on the plastic components and systems used in the manufacturing of pharmaceutical drug products and biopharmaceutical drug substances and products and is one the fundamental documents for manufacturers, especially in the age of single use.
Key Changes in USP <665>
1. Effective Date Extension
The official effective date for USP <665> has been extended to May 1, 2026. This extension is intended to give stakeholders enough time to follow the new requirements and to align with the development of the ICH Q3E guideline for extractables and leachables (E&Ls).
2. Mandatory Compliance
Previously, USP <665> was informational and not mandatory for compendial compliance. The revisions will make it a mandatory chapter, meaning that compliance will be required for regulatory purposes.
3. Risk-Based Assessments
The revised chapter emphasizes risk-based assessments for the qualification of plastic components. This approach aligns with modern regulatory expectations and provides a structured methodology for evaluating the safety and compatibility of materials used in pharmaceutical manufacturing.
4. Scope and Applicability
USP <665> will cover single-use systems (SUS) and container closure systems used in the storage and processing of pharmaceutical and biopharmaceutical products. This includes guidance on the characterization and qualification of these systems to ensure they do not adversely affect product quality.
5. No Grandfathering of Existing Products
The revisions explicitly state that there will be no grandfathering of existing products. All products, including those already on the market, will need to comply with the new requirements by the effective date.
6. Alignment with USP <1665>
USP <665> is closely related to USP <1665>, which provides guidance on the characterization and qualification processes. Together, these chapters offer a comprehensive framework for managing the risks associated with plastic components in pharmaceutical manufacturing.
7. Stakeholder Engagement
The USP has planned to engage with stakeholders throughout the revision process to ensure that the new requirements are practical and achievable. This includes public notices, comment periods, and collaboration with industry experts.
Implications for Manufacturers
Preparation and Compliance
Manufacturers are advised to start preparing for the changes now to avoid potential backlogs and delays. Early compliance will help make sure a smooth transition and keep product quality.
Global Considerations
While the USP is a U.S.-based standard, its guidelines are often adopted globally. Manufacturers should consider the potential for international regulatory bodies to require equivalency to USP <665> compliance in the future.
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