FDA PreCheck can use science-based standards and methods to strengthen U.S. drug manufacturing

Throughout the medicines supply chain, from key starting materials (KSMs) and active pharmaceutical ingredients (APIs) to finished dose forms, manufacturing has increasingly concentrated in just a few regions. Geographic concentration contributes to vulnerabilities and supply disruptions that can cause harmful shortages. 

To expand America’s pharmaceutical manufacturing base and strengthen the resilience of its medicines supply chain, the U.S. Food and Drug Administration (FDA) has launched the PreCheck pilot program. The program offers an early-engagement pathway intended to provide manufacturers with timely, consistent feedback on facility design and quality expectations before operations begin. By surfacing compliance and design risks earlier, PreCheck has the potential to reduce late-stage rework, avoidable delays, and uncertainty during inspection, all toward the goal of making domestic investment more predictable. PreCheck also complements the Commissioner’s National Priority Voucher (CNPV) Program, enhancing dialogue between FDA and industry to move away from traditional, siloed review processes. 

In this context, the U.S. Pharmacopeia (USP) and Pharmatech, the consulting arm of USP, recently submitted comments on the program’s design and implementation. Here, we summarize some practical recommendations to maximize PreCheck’s impact and operational efficiency. 

1. Encourage the use of USP standards in PreCheck submissions 

Sponsors can reference relevant USP general chapters and reference standards within their PreCheck submission application to demonstrate analytical method readiness, PQS maturity, sterility assurance, and PAT/RTRT capability. This structured, cross‑referenced approach helps FDA reviewers to evaluate submissions quickly and systematically, reducing review cycle time and resource strain while supporting risk-based regulatory oversight. 

USP standards and general chapters serve as reference frameworks for quality, validation, and sterility assurance, supporting existing and advanced modalities. These resources, when combined with structured approaches such as clear and complete Validation Master Plans and ICH Q12 lifecycle principles, can provide a harmonized foundation for FDA PreCheck. Regulators benefit from quality, reviewable, and standardized information, while industry gains a clear roadmap grounded in globally recognized science-based standards. Without a structured approach, PreCheck interactions risk being fragmented across individual systems rather than integrated into a holistic readiness plan. 

2. Prioritize facilities that address supply chain risk 

USP Medicine Supply Map data and insights show concerning manufacturing concentration of KSMs, APIs, and finished drug products. Prioritizing PreCheck access for facilities that produce essential and shortage-prone medicines, and for projects that meaningfully onshore or near-shore critical KSMs and APIs, can target early regulatory engagement in areas where single-point failures present the greatest risk. 

Factors such as concentration and complexity of manufacturing can make a drug more vulnerable to shortage. Facilities designed to produce complex or high-risk modalities present unique challenges for FDA evaluation and approval. Science-based standards and implementation methods can provide structure for regulators and clear, de-risked roadmaps for manufacturers. Facilities designed from the ground up for compliance, safety, and quality support the ongoing availability of life-saving medicines. 

3. Build shared capability via pre-competitive platforms 

FDA has long encouraged adoption of Process Analytical Technology (PAT) and Real-Time Release Testing (RTRT) to modernize manufacturing, reduce batch failures, and strengthen quality assurance. Under the PreCheck framework, sponsors may be asked during facility readiness reviews to show, not just that enabling instruments exist, but that the site’s quality system, data governance, and validation approach can reliably support advanced control strategies in routine operation. 

Pre-competitive training and technical assistance can materially raise the baseline. Platforms such as USP’s Advanced Technologies Laboratory and associated education programs can help sponsor teams align on practical expectations for method transfer, lifecycle management, sterility assurance, and what “PAT/RTRT readiness” looks like from both a technical and compliance perspective. 

Pharmatech complements this capability with implementation experience: designing, remediating, and validating facilities where PAT and RTRT are embedded in the control strategy from day one. Successful deployment requires an integrated design-and-validation approach that ties multivariate models, automation, and in-line/at-line measurements to GMP fundamentals: data integrity, change control, deviation management, ongoing verification, and continued process verification. Done well, these elements translate FDA’s intent and USP standards into an operational system that can be sustained through start-up, scale, and inspection. 

4. Expand the PreCheck program to near- and ally-shore facilities 

Broadening the scope of the PreCheck program to include qualified near- and ally-shore facilities could complement U.S. onshoring initiatives by expanding supply chain capacity using existing facilities. This approach could help reduce reliance on adversary countries, provide additional flexibility to address supply chain risks, and promote national security while maintaining high standards for regulatory oversight and patient safety. 

In countries like Mexico, where manufacturers increasingly seek to supply the U.S. market, technical barriers and implementation challenges can delay or prevent facility approvals. Pharmatech’s Jumpstart program, shared earlier this year with the Mexican Association of Pharmaceutical Laboratories (AMELAF), helps manufacturers determine which products are viable for U.S. export and then walks them through the regulatory roadmap, from strategy to mock inspections to submission support. 

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USP and Pharmatech appreciate FDA’s leadership in launching the PreCheck program. We share the agency’s mission to advance efficient, science-based facility readiness and support a resilient U.S. medicines supply chain. In the Federal Register, USP’s full comments can be found here, while Pharmatech’s can be found here.