FDA PreCheck and Quality Management Systems: Accelerating U.S. Drug Production
Introduction
On August 7, 2025, the U.S. Food and Drug Administration (FDA) unveiled the FDA PreCheck program, a strategic initiative designed to strengthen domestic pharmaceutical manufacturing. By accelerating facility readiness and regulatory approvals, FDA PreCheck addresses the nation’s reliance on overseas production while improving the resilience, security, and quality of the U.S. drug supply chain.
At the core of this program is the requirement for a robust quality management system (QMS). A QMS ensures that pharmaceutical manufacturers can meet strict compliance standards, maintain consistent product quality, and demonstrate regulatory maturity—key factors in gaining FDA confidence.
This article explores how FDA PreCheck works, why a quality management system is essential for success, and how digital solutions like TEEXMA for Quality can help manufacturers achieve compliance, efficiency, and long-term operational excellence.
Understanding the FDA PreCheck Program
The FDA PreCheck program introduces a two-phase framework designed to facilitate faster establishment and approval of new U.S. manufacturing sites. The phases include:
1. Facility Readiness Phase
This phase focuses on pre-production readiness by promoting early communication between manufacturers and the FDA. Companies are encouraged to submit a Type V Drug Master File (DMF), detailing:
- Facility layout and operations workflow
- Equipment specifications and process flow diagrams
- Pharmaceutical Quality System elements
- Quality Management Maturity practices
By sharing these details early, manufacturers receive guidance from the FDA to preempt potential compliance issues. This proactive approach significantly reduces delays associated with inspections and regulatory review later in the production lifecycle.
2. Application Submission Phase
The second phase facilitates pre-application meetings and provides early FDA feedback on manufacturing processes and quality controls. By streamlining application submissions and regulatory reviews, the FDA aims to accelerate approval timelines for drugs produced in domestic facilities.
Why Domestic Pharmaceutical Manufacturing Needs FDA PreCheck
Currently, more than 50% of pharmaceuticals distributed in the U.S. are manufactured overseas, with only 11% of active pharmaceutical ingredient (API) manufacturers located domestically. This heavy reliance on international suppliers has become a national security concern, especially in light of recent global supply chain disruptions.
The FDA PreCheck program addresses this vulnerability by incentivizing domestic production. However, building a new manufacturing facility is not just about infrastructure; it also requires robust quality management practices to ensure compliance, consistency, and safety. This is where a Quality Management System becomes a critical asset.
The Role of a Quality Management System in FDA PreCheck Success
A Quality Management System (QMS) is the backbone of pharmaceutical manufacturing. QMS ensures that every step of production, from raw material sourcing to final product release, meets strict regulatory requirements and internal quality standards.
Key Components of a Pharmaceutical Quality Management System
- Document Control – Centralized storage and controlled access to critical documents, including Certificates of Analysis (CoA).
- Change Management – Structured processes for implementing changes in equipment, materials, or procedures.
- Deviation Management – Identification, investigation, and resolution of non-conformities.
- CAPA (Corrective and Preventive Action) – Systematic handling of issues to prevent recurrence.
- Risk Management – Assessment and mitigation of risks across manufacturing processes.
- Audit Management – Scheduling, executing, and tracking internal and external audits.
- Regulatory Compliance Monitoring – Ensuring adherence to cGMP, FDA regulations, and international standards.
- Manufacturing Consistency – Ensuring uniform production processes and product quality across batches.
A well-implemented QMS provides traceability, accountability, and predictability which are key factors for regulatory approvals and operational efficiency.
Enhancing Quality Management System Implementation with TEEXMA
TEEXMA for Quality is a comprehensive digital solution that enhances every aspect of a pharmaceutical manufacturer’s QMS. By integrating document management, process control, and regulatory compliance into a single platform, TEEXMA enables manufacturers to operate more efficiently, reduce errors, and maintain rigorous quality standards.
Centralized Documentation for Compliance
TEEXMA allows organizations to store all quality-related documents in a centralized, secure repository. This includes:
- SOPs (Standard Operating Procedures)
- Batch records
- Equipment qualification protocols
- Regulatory submissions
- Certificates of Analysis (CoA)
Centralized documentation ensures that all stakeholders have access to the most up-to-date information, reducing the risk of errors and non-compliance. It also facilitates real-time collaboration between quality teams, production staff, and regulatory personnel.
Audit Trail Capabilities Supporting FDA PreCheck
TEEXMA provides comprehensive audit trails for all actions performed within the system. Every document modification, approval, or workflow action is recorded, creating transparent traceability that satisfies FDA and ISO regulatory requirements.
Audit trails simplify internal and external inspections, reduce the administrative burden, and ensure accountability across the organization.
Risk Management and CAPA Integration in a QMS
One of TEEXMA’s strengths is its integrated risk management framework. The system allows manufacturers to:
- Identify potential risks in processes, equipment, and supply chains
- Assess the severity and probability of risks
- Implement preventive measures and corrective actions
TEEXMA links risk assessment directly to CAPA workflows, ensuring that identified issues are systematically addressed and mitigated. This proactive approach aligns with the FDA PreCheck program’s emphasis on quality management maturity.
Regulatory Compliance Monitoring with a Digital QMS
TEEXMA ensures that all quality processes comply with cGMP, FDA, and international standards. The system provides real-time monitoring, automated alerts, and compliance dashboards that help manufacturers:
- Track deviations and non-conformances
- Monitor corrective and preventive actions
- Ensure that all documentation is audit-ready
By maintaining continuous compliance, TEEXMA helps manufacturers reduce regulatory risks and expedite product approvals.
Continuous Improvement Through a Quality Management System
Beyond compliance, TEEXMA enables continuous improvement by analyzing performance metrics across quality processes. The system can track:
- Process efficiency and bottlenecks
- Batch yield and defect rates
- Audit and inspection outcomes
Data-driven insights allow organizations to make informed decisions, enhance process efficiency, and maintain high product quality over time.
Integrating TEEXMA for Quality with FDA PreCheck
The FDA PreCheck program emphasizes early engagement with regulatory authorities and the importance of quality management maturity. TEEXMA for Quality directly supports these objectives:
- Early Facility Design and Process Planning: TEEXMA allows manufacturers to document and model facility processes, linking them to quality controls and regulatory requirements. This ensures that facility readiness meets FDA expectations during the PreCheck phase.
- Streamlined Documentation for Type V DMFs: TEEXMA’s centralized repository facilitates rapid preparation of DMF submissions, including detailed process flow diagrams, equipment specifications, and QMS elements.
- Enhanced Communication and Feedback Loops: The system enables cross-functional collaboration between production, quality, and regulatory teams, allowing rapid incorporation of FDA feedback during pre-application meetings.
- Comprehensive Audit Readiness: TEEXMA maintains a complete audit trail for all quality activities, ensuring that manufacturers can demonstrate compliance during FDA inspections.
- Risk-Based Decision Making: With integrated risk management and CAPA workflows, TEEXMA helps organizations proactively address potential issues, aligning with the FDA’s focus on quality maturity and regulatory robustness.
Strengthening Pharma Manufacturing with FDA PreCheck and a Quality Management System
The FDA PreCheck program marks a pivotal shift in U.S. pharmaceutical manufacturing, prioritizing domestic production, faster approvals, and quality management maturity. But success with FDA PreCheck depends on more than new infrastructure—it requires a strong quality management system (QMS) to ensure compliance, product consistency, and regulatory confidence.
By integrating a QMS with the FDA PreCheck framework, pharmaceutical manufacturers can reduce approval delays, strengthen their supply chain, and deliver safe, high-quality medications to patients. Digital solutions like TEEXMA for Quality make this integration seamless, empowering organizations to stay audit-ready, improve efficiency, and continuously enhance performance.
FDA PreCheck sets the framework, but your quality management system makes it sustainable.
Ready to align your pharmaceutical operations with FDA PreCheck? Discover how TEEXMA for Quality can strengthen your quality management system and accelerate compliance.