On June 29, the FDA selected seven companies for the first cohort of its PreCheck Pilot Program.
The agency received more than 80 participation requests before choosing Eli Lilly, Regeneron, Amneal, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics, and Kyowa Kirin. Their proposed facilities will support products ranging from sterile injectables and active pharmaceutical ingredients to biologics and cell and gene therapies.
The selection matters beyond the seven companies involved.
PreCheck is still a limited pilot. It does not create a new requirement for every pharmaceutical project, and participation does not guarantee product approval. But the program provides a clear indication of what the FDA considers important in strategically significant domestic manufacturing projects: earlier regulatory engagement, better-organized facility information, and stronger alignment between design, qualification, quality systems, and future operations.
For pharmaceutical owners planning new facilities or major cleanroom expansions, that is worth acting on now.
PreCheck Moves Facility Readiness Earlier
PreCheck has two phases.
During the Facility Readiness Phase, accepted participants can engage with the FDA while the facility is being designed, constructed, equipped, and prepared for operation. The FDA may review facility design and construction, equipment design and qualification, and elements of the Pharmaceutical Quality System.
Participants will also develop a facility-specific Type V Drug Master File. This creates a central repository for facility information that can later support product-specific applications.
The Application Submission Phase builds on that work through facility-focused pre-submission engagement, earlier evaluation of facility information, and the potential for inspections earlier in the application review cycle.
The practical lesson is straightforward:
Facility readiness cannot begin at turnover.
By the time a project reaches closeout, many of the decisions that determine readiness have already been made. The owner requirements have been written. Vendors have been selected. Equipment has been purchased. Documentation expectations have either been defined—or left open to interpretation.
If the project lacks structure at those earlier stages, the owner usually inherits the gap.
Why This Matters Beyond the Initial Cohort
Most pharmaceutical facility projects do not fail because the engineering is fundamentally wrong.
They struggle because the information needed to operate, maintain, qualify, and defend the facility is fragmented across owners, designers, contractors, vendors, and consultants.
A system may be properly installed but supported by incomplete turnover records. A cleanroom may meet its performance requirements while cleaning, maintenance, or operating expectations remain unclear. Equipment packages may contain hundreds of documents without providing a usable connection to the owner’s requirements or asset structure.
These problems tend to surface late, when the team is already managing construction closeout, commissioning, qualification, SOP development, training, maintenance planning, and startup.
At that point, documentation problems become schedule problems.
The PreCheck pilot does not impose its structure on every owner. It does, however, reinforce a direction that owners should recognize: the facility record must develop alongside the facility itself.
That requires more than collecting documents. It requires deliberate owner-side planning.
Five Actions Owners Should Take Now
1. Strengthen the URS
The user requirements specification should guide more than design and equipment selection.
It should connect process needs, GMP expectations, operational requirements, maintenance considerations, data requirements, cleaning expectations, and future documentation needs.
A vague URS creates ambiguity that follows the project into procurement, execution, qualification, and operation. A strong URS gives the owner a basis for evaluating design decisions, vendor responses, testing, and final delivery.
2. Define Documentation Requirements in the RFP
Owners should not rely on a vendor’s standard documentation package.
The RFP should identify the drawings, manuals, records, certificates, data, procedures, spare-parts information, and turnover materials required for the project. It should also define formats, naming conventions, review expectations, delivery dates, and acceptance criteria.
Once a vendor has completed its work and demobilized, the owner has far less leverage to correct missing or inadequate documentation.
3. Establish Document Ownership Early
Every critical project and facility document should have a defined owner.
The team should know who creates it, who reviews it, where it is maintained, what requirement it supports, and when it becomes part of the controlled facility record.
Without clear ownership, documents are duplicated, overlooked, stored in multiple locations, or allowed to become obsolete.
4. Map Turnover Before Closeout
Turnover planning should begin while the project is still being structured—not after installation is substantially complete.
Owners should define the required turnover packages by system, area, or asset and determine what each package must contain. They should also identify how those packages will support commissioning, qualification, maintenance, operations, training, and quality review.
Turnover should confirm that the project delivered what the owner required. It should not become an exercise in reconstructing the project after the work is complete.
5. Put Operational Readiness on the Project Schedule
Operational readiness should be managed as an active project workstream.
SOP development, staffing, training, asset setup, preventive maintenance, spare parts, cleaning strategies, document approval, and operating procedures all have dependencies. They require responsible owners and realistic completion dates.
When these activities remain outside the integrated schedule, they often become late-stage surprises that delay startup or transfer risk to the operating organization.
The Owner’s Role Is to Create the Connection
Designers, contractors, CQV teams, quality groups, vendors, and operations personnel each bring critical expertise to a pharmaceutical facility project.
But no individual participant is responsible for connecting the entire facility record unless the owner establishes that responsibility.
That connection begins with clear requirements. It continues through procurement, vendor management, document control, turnover planning, and operational readiness.
The FDA’s first PreCheck cohort gives seven manufacturers a formal structure for earlier facility engagement. Other owners do not need to wait for participation in a future cohort to apply the underlying lesson.
The earlier the facility, documentation, and operating models are connected, the easier it becomes to manage execution, support qualification, prepare for startup, and maintain control after the project team leaves.
How Hygenix Supports Facility Readiness
Hygenix helps pharmaceutical owners establish the requirements, documentation structure, vendor expectations, turnover strategy, and operational-readiness planning needed to keep these workstreams connected.
We work alongside owner, design, construction, CQV, quality, and operations teams to close the gaps that frequently appear between project delivery and facility operation.
For owners planning a new pharmaceutical facility, cleanroom expansion, or major readiness effort, the right time to create that structure is before procurement and execution make the gaps more difficult and expensive to correct.