1. USP provides the scientific foundation for medicine quality, across modalities

USP develops independent, public quality standards that define identity, strength, quality, and purity of medicines. These standards help ensure the consistency and reliability of pharmaceutical manufacturing processes and products—from Active Pharmaceutical Ingredients (APIs) and excipients to finished dosage forms for small molecules medicines and increasingly for biologics, biosimilars, and advanced therapies.

Developed through expert consensus, public input, and rigorous evaluation, USP standards create a shared scientific language that manufacturers and regulators rely on worldwide.

2. USP, industry, and regulators work together by design to develop meaningful solutions to quality problems

USP, regulators, and industry each play a distinct but connected role.

• USP establishes public quality standards and solutions through transparent, expert-driven processes.
• Industry contributes data, methods, and real-world expertise to ensure standards reflect approved products and evolving technologies.
• Regulators, including U.S. Food and Drug Administration (FDA), rely on and enforce those standards as part of their oversight of safety and efficacy.

This collaboration is critical for alignment across quality systems and bringing medicines to market efficiently, especially as new therapies grow more complex and analytical expectations continue to evolve.

3. Early engagement with USP supports better regulatory outcomes 

Engaging with USP early—during product development or compendial planning—helps standards stay aligned with current science, validated methods, and regulatory expectations. 

For both small molecules and biologics, early collaboration can:

• Improve clarity and applicability of standards
• Support smoother regulatory reviews
• Reduce uncertainty around analytical methods and specifications

Manufacturers can engage through monograph submissions, public comment, data and sample contributions, and reference standards development.

4. Public standards support regulatory predictability and confidence

Robust, publicly available standards help reduce ambiguity for both sponsors and regulators. Because USP methods and acceptance criteria are already recognized by FDA, companies often reference them in in Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), supplements, and comparability protocols.

For manufacturers, this can mean:

• Fewer questions during review
• Clearer expectations for quality testing
• More predictable regulatory outcomes

The same principles apply as standards expand to address potency, purity, and performance challenges unique to biologics.

5. USP standards evolve with innovation in science and technologies

Technology doesn’t stand still, and neither do USP standards. Through structured revision processes involving industry, regulators, and expert volunteers, USP modernizes monographs and analytical approaches while maintaining regulatory alignment.

This approach helps ensure standards remain:

• Scientifically current
• Fit for purpose across modalities
• Supportive of innovation, including biosimilars, gene therapies, and advanced biologics.