FDA’s New PreCheck Program: What Manufacturers Should Know and How to Prepare

What PreCheck actually is

At its core, PreCheck is a voluntary pilot program that allows selected manufacturers to interact with the FDA before formal regulatory submissions.

The program consists of two phases.

• The first phase, Facility Readiness, allows companies to engage with the FDA during site design and construction by sharing facility plans, quality systems, and state-of-readiness strategies.
• The second phase, Application, includes pre-submission meetings and earlier inspections to help minimize downstream review issues.

Whether your project is in the conceptual phase or under construction, this program can help ensure timely delivery and long-term compliance.

What Precheck Isn’t:

Applying for PreCheck does not guarantee faster approvals, but it aims to reduce late-stage issues and enhance predictability.

For most facility owners, predictability is as valuable as speed.

Who it’s for

The pilot is focused on:

• New facilities located in the U.S.
• It does not apply to simple expansions or renovations.
• Projects tied to domestic drug manufacturing or critical medicines

If you are planning a greenfield facility for sterile, injectable, biologics, or other regulated manufacturing, this program likely applies to your project.

The timeline (this is already underway)

The program is currently active.

According to the FDA’s rollout:

• February 1, 2026 – Applications opened
• March 1, 2026 – First submission deadline
• April 2026 – Finalists notified
• June 30, 2026 – First cohort selected
• Later in 2026, Pilot engagement begins.

Companies are already adopting this approach and planning projects accordingly.

Why this matters for facility design and construction

From a facility perspective, PreCheck changes the traditional project sequence.

Historically:
Design → Build → Validate → FDA review → Fix what breaks

With PreCheck:
Design → Align early with FDA → Build → Validate → Submit

Real-life implications for your project:

• Fewer redesigns
• Fewer late-stage remediation costs
• Smoother inspections
• Better schedule certainty

This approach also moves expectations to earlier project stages.

Compliance considerations should begin during design, not be postponed until CQV or inspection preparation. Providing clear documentation early and collaborating with GMP experts can save time and reduce risk.

First steps manufacturers should take

Even if you do not apply to the pilot immediately, preparing for this type of engagement is considered best practice.

Here’s where to start.

Confirm eligibility early
If you are building a new U.S. facility, especially for sterile or high-risk manufacturing, assess whether PreCheck participation is appropriate. This decision should be made early in the project.

Move compliance to the front of the project.
Treat regulatory requirements as design inputs.
URS, classifications, airflow strategies, material selections, and finishes should be based on GMP principles. Each decision should have a clear, documented rationale.

Get documentation moving sooner.
Expect to have the following ready earlier than usual:

• facility descriptions
• quality systems
• commissioning strategies
• validation plans

This documentation is often completed only at turnover, which can delay CQV. Delays at this stage may significantly affect project schedules.

Integrate CQV thinking during design.
Plan testing during the design phase rather than after construction is complete.

Begin risk assessments, traceability, and acceptance criteria early so that validation serves as confirmation rather than discovery.

Align your project team.
PreCheck encourages coordination among engineering, quality, construction, and regulatory teams throughout the process. Lack of collaboration becomes apparent early.

Involving all stakeholders early facilitates smoother internal communication and communication with the FDA.

Beyond this pilot, the industry direction is clear.

• FDA wants earlier visibility
• They want fewer surprises
• And they expect facilities to be inspection-ready sooner

PreCheck is likely not a one-time initiative but reflects the industry’s future direction. Designing facilities correctly from the outset supports the shared goal of providing safer and more affordable drugs.

Companies that plan accordingly now will face fewer challenges later.

A practical note from our side

At Precision Environments, we view this shift as a reinforcement of long-standing practices rather than a dramatic change in philosophy.

Projects proceed more smoothly when compliance is integrated into design and quality, regulatory, and manufacturing teams collaborate from the outset.

When URS, airflow strategies, room classifications, materials, and commissioning plans are addressed during design, inspections are typically straightforward. Delaying these discussions often leads to costly fixes and schedule delays.

Programs like PreCheck simply formalize that idea.

Regardless of pilot participation, the same approach applies: design with intent, document rationale, and be prepared to justify decisions early. This mindset reduces risk for all GMP facilities, not only PreCheck projects.

The Bottom Line

Sufficient information is available to take action.

If you are planning a new pharmaceutical or sterile manufacturing facility in the next one to two years, now is the time to:

• Evaluate eligibility
• Tighten early planning
• Strengthen documentation
• Treat compliance as part of design, not a final hurdle.

With over 35 years of experience designing and delivering GMP facilities, Precision Environments has seen what happens when compliance is an afterthought, and what’s possible when it’s built in from day one. Whether you’re evaluating PreCheck eligibility, tightening your early-stage documentation, or planning a new facility from the ground up, we can help you get it right the first time.