On June 29, 2026, FDA announced the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative intended to advance U.S. drug manufacturing and improve regulatory predictability for new domestic pharmaceutical manufacturing facilities.

The program is designed to give FDA earlier visibility into facility design, construction, pre-production planning, manufacturing readiness, and quality system development. In other words, FDA is not waiting until the facility is finished to start asking questions.

For companies building or expanding pharmaceutical manufacturing capacity, this is an important signal: facility readiness is not just an engineering milestone. It is a quality system milestone.

What FDA PreCheck is trying to solve

New manufacturing facilities can run into avoidable delays when regulatory expectations, facility design, validation planning, and quality system development are not aligned early enough.

FDA PreCheck is intended to create earlier communication between FDA and selected manufacturers during key stages of facility development. The program includes two main phases:

1. Facility readiness and design communication during facility design, construction, and pre-production activities
2. Application readiness support, including pre-application meetings and early feedback on manufacturing and quality information

This matters because the same issues that delay inspections and approvals often start long before the application is submitted. Facility layout, equipment strategy, contamination controls, utilities, data systems, material flows, staffing plans, supplier controls, and validation planning all become part of the eventual regulatory story.

Why this matters for Quality

A new facility can look ready from a construction standpoint and still be unprepared from a quality standpoint.

For quality teams, the lesson is straightforward: do not wait until the facility is built to begin thinking like an inspector.

A strong readiness strategy should connect:

• Facility design and process flow
• Contamination control and cleaning strategy
• Equipment qualification and process validation
• Utility qualification
• Supplier and material controls
• Data integrity and computerized systems
• SOPs, training, and staffing
• Deviation, CAPA, and change control systems
• Batch record and documentation readiness

If those systems are built late, the site may end up with beautiful infrastructure but weak inspection evidence.

The inspection-readiness trap

One of the biggest risks in facility expansion is treating inspection readiness as the final phase of the project.

In reality, inspection readiness begins when teams make early design and process decisions. For example:

• A facility layout decision may affect contamination control.
• A utilities decision may affect qualification strategy.
• An equipment selection decision may affect validation scope.
• A software platform decision may affect data integrity controls.
• A supplier decision may affect material qualification and change control.

By the time FDA or another regulator is reviewing the site, those decisions need to be explainable, documented, and traceable.

What companies should do now

Even if your company is not part of the PreCheck pilot, the message still applies. FDA is emphasizing earlier alignment between manufacturing development and regulatory expectations.

A practical readiness approach should include:

1) Build a facility readiness roadmap early

Create an integrated plan that connects construction milestones with quality system milestones. Do not separate “building the facility” from “building the QMS.”

2) Create a regulatory evidence map

Identify what evidence will be needed to support facility readiness, process validation, cleaning validation, utilities, supplier controls, computerized systems, and batch release.

3) Involve Quality before major design decisions are locked

Quality should have a seat at the table during facility layout, equipment selection, process flow planning, material movement strategy, and data system decisions.

4) Pressure-test the validation strategy

Before qualification and validation work begins, confirm that your strategy is risk-based, scientifically justified, and aligned with the intended commercial process.

5) Prepare the inspection story before the inspection

Teams should be able to explain not only what was done, but why it was done, how risks were controlled, and where the supporting evidence lives.

A practical facility readiness checklist

Before a new or expanded facility moves toward regulatory review, ask:

• Are facility design decisions tied to process and contamination-control risks?
• Is there a clear qualification and validation master plan?
• Are utilities, equipment, and computerized systems mapped to quality impact?
• Are supplier and material controls established before production begins?
• Are SOPs, training records, batch records, and deviations inspection-ready?
• Is change control active during construction and technology transfer?
• Can the team explain the readiness story clearly and consistently?

Bottom line

FDA PreCheck is a pilot program, but the message is bigger than the pilot: regulatory readiness now starts earlier.

For companies building new pharmaceutical manufacturing capacity, the strongest approach is to integrate quality, validation, regulatory, engineering, and operations from the beginning.

A facility is not truly ready when construction is complete. It is ready when the process, people, systems, controls, and evidence can stand up to regulatory review.

If your organization is building, expanding, transferring, or preparing a manufacturing site for approval, QSN can help pressure-test the facility readiness plan, validation strategy, quality system buildout, and inspection narrative before they become approval delays.