We recognize the important role of biological medicines in patient care. We are committed to ensuring that our approach evolves with the science of biologics and the needs of stakeholders, including patients, practitioners, industry and regulators. We are developing standards that are broadly applicable across biological products, and delivering solutions to address the quality of raw materials as well as the development of performance standards which support analytical testing throughout the product lifecycle. Watch the video below for additional information.
We continue to engage FDA, industry and other stakeholders about how best to evolve our approach for biologics standards. Below is information that further clarifies USP’s commitment to early and continuous engagement.
1. How does USP plan to encourage stakeholder engagement?
A key element of our engagement approach is to actively gather early input including practitioner, industry and regulator views that would occur prior to any decision to move forward with the development of a biologic standard. Early engagement with stakeholders will help determine which approach is most appropriate. The graphic below illustrates this overall process.
2. When does the engagement begin?
After receiving a submitted request to develop a standard, USP will perform an initial outreach to identify impacted stakeholders and evaluate the need for the proposed standard. We will conduct a call for early input from stakeholders regarding the potential standard-setting activity and seek feedback before proceeding further. Stakeholders will be encouraged to provide feedback on whether a standard should be developed, the kind of standards that could be developed, and the associated public health, scientific and regulatory considerations.
3. What are the types of biologics standards that could be developed?
USP’s standards vary depending on the need and could include the following:
- reference standards (may or may not be tied to an official documentary standard in the USP-NF)
- applicable general chapter
- informational general chapter (designated above “1000”) or best practices documents (e.g., white paper, publish on USP website, peer reviewed article)
- monographs – single, multiple, or flexible.
Furthermore, USP may determine that a standard is not necessary or feasible.
4. What kinds of monographs does USP develop?
Based on stakeholder input, we can develop substance or product monographs. Different monograph approaches could include:
- multiple monographs – different monographs for unique products that have been approved
- flexible monograph – one monograph with additional distinctions between approved products clarified using the monograph labeling or definition sections
- single monograph – one monograph for multiple approved products
5. When will USP develop product specific monographs?
USP will not publish as official new monograph standards for specific biologics products unless supported by FDA and stakeholders.
6. What are USP performance standards?
Performance standards are used to ensure and demonstrate method and process performance. They are broadly targeted at product families or classes as opposed to a specific drug substance or drug product. USP’s performance standards are intended to address common quality challenges associated with technologies that cut across different types of products (e.g. system suitability samples, calibrators used to demonstrate performance of an analytical procedure, process or equipment).
7. Are USP performance and raw material standards developed using the same process as other USP standards?
USP’s performance and raw material standards are developed using the same controlled process, quality systems and scientific review by staff and Expert Committees as other USP standards. In addition, their suitability for use will be established using multi-laboratory collaborative studies.
8. What are the following steps once a decision has been made to pursue a biologic standard?
After input from stakeholders has been obtained and there is an interest and support in proceeding with developing a standard, USP will provide public notice to stakeholders and may obtain additional feedback by posting a prospectus, hosting workshops or roundtables, and published articles.
After such engagement and input, the appropriate USP Expert Committee could proceed by publishing the standard in the Pharmacopeial Forum (PF) for a public review and comment period. The Expert Committee will evaluate the comments and proposed approach taken (e.g., monograph, general chapter) before finalizing and publishing the standard as official in the USP-NF. USP standards that have been finalized and become official go through continuous improvement and revisions.
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