GxP Insights: FDA PreCheck Pilot Goes Live: A New Era for Domestic Manufacturing Oversight?

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This month, we examine the formal launch of the FDA’s PreCheck pilot program and what it signals for domestic manufacturing, regulatory predictability, and workforce demand across the US.

FDA officially launches PreCheck pilot program

On 1 February 2026, the US Food and Drug Administration (FDA) began accepting requests to participate in its PreCheck pilot program, marking a significant step in the agency’s push to strengthen domestic pharmaceutical manufacturing and supply chain resilience.

First announced in August 2025 and developed in response to President Donald Trump’s executive order in May 2025 on promoting domestic pharmaceutical manufacturing, the program is designed to reduce regulatory barriers for domestic manufacturing facilities by:

• Increasing regulatory predictability
• Facilitating the construction of new US manufacturing sites
• Streamlining elements of pharmaceutical manufacturing facility assessments before a product application is submitted.

FDA Commissioner Dr Marty Makary described the PreCheck program as “one of several powerful incentives” aimed at making the US pharmaceutical manufacturing sector “more resilient and competitive.”

Requests to participate in the pilot were due by 1 March 2026. The FDA will now select an initial cohort of seven participants, based on alignment with national priorities, with final selections expected by 30 June 2026. Importantly, the program is restricted to new facilities only; industry requests to include existing sites were not accepted.
 

How PreCheck is structured

PreCheck introduces a two-phase model designed to bring regulatory engagement much earlier in the facility lifecycle and create more efficient regulatory review processes for new pharmaceutical manufacturing facilities.

Phase 1: Facility Readiness

In this phase, selected manufacturers can engage with FDA before the facility becomes operational.

This includes:

• Early technical advice and pre-operational reviews
• Early reviews of facility design and development
• Use of a facility-specific Drug Master File (DMF) to streamline the evaluation of unique facility elements prior to and in support of submitting a drug application
• Feedback on quality systems and manufacturing controls

The goal is to identify potential compliance gaps before they impact a future submission.

Phase 2: Application Submission

The second phase builds on the groundwork laid in Phase 1.

It includes:

• Pre-submission meetings and inspections to address and resolve any issues
• Streamlined review of manufacturing information included in product applications

By engaging earlier and more frequently, FDA aims to reduce late-stage regulatory surprises and accelerate assessments tied to commercial launch. 

Selection criteria and eligibility

Facilities must meet the following requirements to be eligible for the PreCheck Pilot Program:

• Be domestic new-build sites (not extensions of existing facilities)
• Have broken ground, will break ground by the pilot full proposal deadline, or be in the pre-operational development
• Intend to manufacture human drugs and/or biological products
• Produce sufficient volume to meet a specified market need
• Commit to submit an original New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA), or application supplement for drug substance (DS), FDF/drug product (DP), or a Type II DMF for small molecule APIs for the new manufacturing facility during the PreCheck Pilot Program
• And commit to actively manufacturing the product at the site for at least three years post-FDA approval.

The FDA said additional priority consideration will be given to facilities producing products that address drug shortages, critical medicines, or key supply chain vulnerabilities.

Selection criteria include:

• Product type
• Phase of facility development
• Speed to US market supply
• Innovation in facility design or manufacturing approach

This aligns regulatory incentives with reshoring, advanced manufacturing adoption, and supply-chain security goals.

Why this matters in 2026

According to the FDA, more than half of pharmaceuticals distributed in the US are manufactured overseas, with only 11% of Active Pharmaceutical Ingredient (API) manufacturers US-based, creating significant national security vulnerabilities. 

The past five years have exposed vulnerabilities in global supply chains, from pandemic disruption to geopolitical tension. At the same time, drug shortages, tariffs and reshoring pressures, national security concerns, executive policy direction, and demand growth (GLP-1s, biologics, CGT, etc.) have meant unprecedented capital has flowed into US-based manufacturing expansion.

Major manufacturers have announced multi-billion-dollar investments across:

• Biologics and sterile injectables
• Small molecule API reshoring
• GLP-1 and metabolic therapies
• Cell and gene therapy capacity
• Continuous and digitally enabled manufacturing platforms

Check out the December edition of GxP Insights to find out more about the surge in US-based pharmaceutical manufacturing.

PreCheck signals a regulatory shift that matches this industrial shift, from reactive inspection to earlier, structured engagement.

If successful, it could shorten timelines between facility construction and commercial approval, improve inspection readiness, and reduce uncertainty for large capital projects.

The talent impact: skills in demand

Earlier engagement and higher technical expectations will inevitably intensify demand for specialized talent. Workforce availability, not capital, will remain the primary constraint. Skillsets seeing particular growth include:

Construction & Capital Project Delivery

• GMP-compliant facility design and build oversight
• Cleanroom construction and critical utility installation
• Commissioning and start-up coordination
• Design control documentation and regulatory alignment during build phase

Validation & CQV Engineering

• Facility qualification (IQ/OQ/PQ)
• CSV and digital system validation
• Cleaning and process validation
• Utility qualification

Quality Systems & Inspection Readiness

• Mock inspection leadership
• CAPA and risk management
• Data integrity programs
• Facility-level QMS buildout

Regulatory Affairs & CMC

• Facility strategy alignment with FDA engagement
• NDA/ANDA/BLA manufacturing sections
• DMF preparation and lifecycle management
• Advanced manufacturing submissions

Automation & Digital Manufacturing

As PreCheck supports innovation in facility development:

• MES / SCADA integration
• Continuous manufacturing controls
• Real-time release testing
• Digital batch record oversight

MSAT & Process Engineering

• Tech transfer into new facilities
• Process control strategy
• Scale-up documentation
• Risk-based control frameworks

Live GMP projects as part of US manufacturing expansion

As domestic build programmes accelerate, we are actively supporting multiple large-scale construction, commissioning, and manufacturing projects across the East Coast and Midwest.

Our current live contract requirements include:

• Quality Manager, Lebanon, Indiana (onsite)
• Technical and Design Resource, Lebanon, Indiana (onsite)
• Utilities SME, Philadelphia, Pennsylvania (hybrid)
• Bulk Area Lead, Philadelphia, Pennsylvania (hybrid)
• Validation Consultant (Head of Validation), North Carolina (onsite)
• Lead Process Engineer (Bulk Operations Subject Matter Expert), North Carolina (hybrid)
• Automation Engineer, Pennsylvania (onsite)
• Senior Automation Engineer, Pennsylvania (hybrid)
• Automation DeltaV Area Lead, Indiana (onsite)
• Automation PLC Area Lead, Indiana (hybrid)

If you’re exploring your next move or would like to become part of our network for upcoming projects, we’d be happy to connect.

Final thoughts

PreCheck represents more than a pilot initiative. It reflects a broader alignment between federal policy, regulatory practice, and industrial investment.

As domestic manufacturing scales, success will depend not only on incentives and capital, but on technical readiness, regulatory fluency, and access to the right expertise at the right time.

At i-Pharm GxP, we work alongside the Life Sciences organizations navigating this shift, helping them secure the expertise required to build, validate, and sustain next-generation manufacturing.

If you’d like to discuss opportunities or expertise needs, we’d love to connect. 

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