1. Introduction
In pharmaceutical manufacturing, the margin for error is virtually zero. Equipment must consistently operate within strict parameters to ensure product quality, patient safety, and regulatory compliance.
One of the most critical checkpoints before equipment reaches the production floor is the Factory Acceptance Test (FAT). Conducted at the vendor’s manufacturing site, FAT verifies that the equipment or system:
- Meets the User Requirements Specification (URS)
- Complies with Good Manufacturing Practice (GMP) standards
- Is ready for smooth installation, commissioning, and qualification on-site
This stage can prevent costly delays, reduce installation issues, and mitigate regulatory risks before the equipment ever leaves the factory.
2. What is Factory Acceptance Testing (FAT)?
A Factory Acceptance Test is a structured, documented testing process carried out at the manufacturer’s facility.
It is more than just a “trial run” — it is a formal quality gate where performance, safety, and compliance are verified under controlled conditions.
The FAT process typically involves:
- Reviewing design and engineering documentation
- Performing functional and operational tests
- Verifying automation and control systems
- Checking safety systems and alarms
- Confirming material compatibility with the pharmaceutical product
- Completing documentation for validation
3. FAT in the GMP Lifecycle
In the GMP validation framework, FAT sits between Design Qualification (DQ) and Site Acceptance Testing (SAT).
A simplified sequence looks like this:
- Design & Engineering Phase
- URS, functional specifications, and design documentation are finalized.
- FAT(Vendor Site)
- Equipment is tested against functional requirements.
- Delivery & Installation
- Equipment shipped and set up at the client’s facility.
- SAT(Client Site)
- Final verification in the real production environment.
- IQ, OQ, PQ
- Installation Qualification, Operational Qualification, and Performance Qualification.
This structured approach ensures that by the time the system is installed, most potential issues have already been addressed.
4. Objectives of FAT
The core purposes of FAT include:
- Verification of design compliance with URS and GMP requirements.
- Operational performance validation under test or simulated conditions.
- Documentation completeness for regulatory submission.
- Early defect detection before site delivery.
- Reduction of commissioning time at the client site.
5. FAT Process – Step-by-Step
A standard FAT will often include:
| Step | Description |
|---|---|
| 1. Preparation | FAT protocol creation, approval of test scripts, review of URS and FS. |
| 2. Pre-FAT Review | Verify fabrication completion, documentation readiness, and calibration. |
| 3. Visual Inspection | Check weld quality, material certificates, surface finishes, and cleanliness. |
| 4. Functional Testing | Run processes with water or simulants; verify automation sequences. |
| 5. Safety Verification | Test alarms, interlocks, and emergency stop functions. |
| 6. Documentation Review | Verify manuals, drawings, software validation documents, and calibration certificates. |
| 7. Deviations & Corrections | Record non-conformities and corrective actions. |
| 8. FAT Report & Sign-off | Approve and release equipment for shipment. |
6. Best Practices for FAT Success
- Develop a comprehensive FAT protocol — including acceptance criteria aligned with GMP and ICH Q9 principles.
- Involve cross-functional teams — Quality Assurance, Engineering, Operations, and Automation specialists.
- Simulate actual operating conditions as closely as possible.
- Leverage remote FAT tools to engage global teams without travel.
- Apply ALCOA+ principles to ensure FAT data integrity (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, and Available).
7. Modern Trends in FAT
- Remote FAT (rFAT) – Live video streaming, augmented reality, and secure data sharing platforms allow FAT participation without travel.
- Integration with Industry 4.0 – IoT-enabled sensors provide real-time operational performance metrics.
- Risk-Based FAT – Focused testing based on a GMP risk assessment to allocate effort where failure risk is highest.
- Sustainability in FAT – Virtual FAT sessions reduce environmental impact by minimizing travel.
- Digital Twin Testing – Using virtual models to simulate performance scenarios before physical FAT.
8. Challenges in FAT Execution
- Incomplete URS leading to scope changes.
- Mismatch between FAT and site utilities (e.g., power supply differences).
- Data integrity lapses when documentation is manual or inconsistent.
- Vendor-client communication gaps during test execution.
- Delays caused by defect resolution or missing components.
9. Conclusion
Factory Acceptance Testing is not just a technical formality — it’s a strategic quality milestone that can make or break a pharmaceutical project’s success.
By applying structured protocols, risk-based thinking, and digital tools, pharmaceutical companies can:
- Reduce project timelines
- Minimize costly rework
- Improve GMP compliance
- Accelerate time-to-market for life-saving medicines
As pharma manufacturing evolves toward digitalization and global collaboration, FAT is also transforming — from a traditional on-site inspection into a data-driven, remotely accessible, and risk-optimized quality gate.
References
- ISPE. https://ispe.org
- European Medicines Agency. EudraLex Volume 4: GMP Guidelines Annex 15 Qualification and Validation. EMA, 2015. https://health.ec.europa.eu
- FDA. Data Integrity and Compliance with Drug CGMP. FDA Guidance for Industry, 2018. https://fda.gov/media/119267/download
- ICH. Q9(R1) Quality Risk Management. International Council for Harmonisation, 2023. https://www.ich.org
- ISPE. https://ispe.org/pharmaceutical-engineering