Key points:
- USP is engaged with both FDA and industry in its transparent, science driven standards development process to support broad applicability, and alignment with regulatory expectations.
- Early industry engagement with USP—such as sharing data, submitting methods, and providing public comments—helps ensure evolving standards reflect real world practices and improve clarity across regulatory pathways.
- USP monographs and General Chapters offer a common scientific foundation that companies can reference in FDA submissions, helping streamline reviews and reinforce shared expectations for quality.
Read the second part in the series here.
USP recently co-hosted a webinar with experts from the U.S. Food and Drug Administration (FDA) and the Association for Accessible Medicines (AAM) to examine how public quality standards help contribute to regulatory predictability. Attendees, including regulatory affairs professionals, scientific and technical professionals from across the industry, and consultants specializing in standards and compliance, submitted hundreds of questions for panelists—far too many to cover during the session. Quality Matters sat down with Matt Vankoski, USP Director of Donations, to discuss the most commonly asked audience questions—as well as a few he was unable to address live—in a two-part series.
Q: When it comes to developing quality standards for medicines, how do USP, regulators, and industry interact? What are the distinct roles and how do they collaborate?
Matt: Here’s a very high-level overview: USP develops public quality standards through an independent, transparent, and scientifically rigorous process relying on Expert Committees comprised of independent Expert Volunteers and public comment. USP plays a critical role in establishing the scientific foundation of public standards that helps ensure the quality, consistency, and reliability of pharmaceutical products.
FDA is responsible for ensuring the safety and efficacy of pharmaceutical products marketed in the United States. Companies who want to market a pharmaceutical product in the U.S. must first apply for FDA approval, most commonly through the New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) process. As a matter of policy, USP relies on scientific information provided by manufacturers whose articles were previously FDA-approved or otherwise legally marketed to support new and revised compendial standards.
FDA enforces laws and regulations designed to ensure the safety and effectiveness of pharmaceutical products and is also responsible for enforcement of USP standards. The agency maintains extensive coordination with USP—including through dozens of FDA staff who participate as government liaisons on USP Expert Committees and Panels to promote alignment between USP’s public standards and regulatory thinking.
Industry’s role in the standards development process is to contribute scientific data, reference materials, and practical expertise to support the creation of robust, science-based standards that reflect their approved product. Active participation from industry helps ensure that standards keep pace with evolving technologies and reflect real-world conditions.
Q: One of the themes we heard from all speakers was to encourage early engagement with USP by industry. How does such engagement lead to better regulatory outcomes, and how can companies engage?
Matt: Early collaboration in the context of supporting standards development means engaging with USP at the onset of your product development or compendial planning process. This allows USP to incorporate contemporary practices, industry-proven validated methods, and diverse data sources into monographs and General Chapters. This helps improve clarity, broad applicability, and alignment with regulatory expectations. Pathways for engagement with USP include:
- Submission of a new proposed monograph or revision to existing USP standards to maintain alignment with current scientific advancements.
- Routine review of/commenting on proposals in Pharmacopeial Forum (PF) during public comment periods
- Contribution of analytical data and samples
- Involvement in Pending Monograph Process revisions during FDA application review
- Support for USP Reference Standards development
Q: What do you mean by “regulatory predictability” when discussing the role of standards?
Matt: Regulatory predictability refers to the degree of clarity and consistency that both manufacturers and regulators gain from robust, science based, publicly available standards. USP monographs and associated General Chapters define identity, strength, quality, and purity specifications that reflect established regulatory expectations and form a common scientific foundation for product quality. In the U.S., these standards hold legal relevance under the Federal Food, Drug, and Cosmetic Act, helping reduce ambiguity during development, review, and inspection processes.
In addition, USP standards play a practical and often strategic role when companies prepare submissions or other communications to FDA. Because USP monographs and General Chapters articulate validated analytical procedures, system suitability criteria, and acceptance criteria that FDA already recognizes, sponsors frequently reference these standards in Investigational New Drug Applications (INDs), NDAs/ANDAs, supplements, comparability protocols, and formal responses to Information Requests. Doing so can help demonstrate that product quality testing is grounded in a publicly vetted, scientifically rigorous framework.
When applicants rely on USP methods, they can offer FDA a level of transparency and predictability that helps expedite regulatory assessments. For industry, this can mean fewer questions, clearer expectations, and a reduced risk of delays related to analytical methods, specifications, or test performance. By grounding submissions in compendial standards, companies signal alignment with well understood quality benchmarks, helping support more efficient review cycles and more predictable regulatory outcomes.
Q: Can companies use their own validated analytical methods, or must they use USP monograph methods?
Matt: USP permits the use of alternative methods when they are fully validated and demonstrated to be equivalent or better in meeting the intent of the compendial requirements. Under General Notices 6.30, validated alternative procedures are acceptable, provided they achieve comparable accuracy, precision, and specificity. Relevant guidance on method validation is provided in <1225> Validation of Compendial Methods and, where applicable, <1223> Validation of Alternative Microbiological Methods.
When using compendial methods, users must verify suitability of methods under actual conditions of use. Guidance on verification of USP methods is provided in <1226> Verification of Compendial Methods. Compendial methods are designed to evolve over time, and USP strongly supports innovation in this area. If you have a qualified alternative method, we are open to working with you to review and update the compendial requirements as appropriate.
Q: How does USP maintain consistency and regulatory alignment when modernizing monographs and updating analytical technologies?
Matt: We acknowledge that technology is constantly advancing, and USP has implemented a process that actively involves industry and FDA to ensure that standards remain accurate, consistent, and fit for purpose.
USP follows a rigorous, transparent revision process involving scientific data evaluation, Expert Committee review including participation from FDA government liaisons, and public notice and comment. USP communicates implementation timelines to ensure laboratories can adopt changes appropriately. This structured communication helps manufacturers, regulators, and testing laboratories understand the scientific basis for revisions and prepare for their integration into quality systems. The result is a standards framework that remains current with evolving analytical capabilities while continuing to align with regulatory expectations for clarity, reliability, and public health protection.
In part two, we’ll discuss global harmonization of standards, how organizations can participate in standards-setting activities with USP, what training and education resources are available, and more.
