Factory Acceptance Testing (FAT) plays a crucial role in the Commissioning, Qualification, and Validation (CQV) lifecycle, especially for industries regulated by stringent quality standards, such as pharmaceutical and biopharmaceutical manufacturing. FAT is performed before equipment is shipped to the installation site, providing an opportunity to verify that the system meets the defined specifications and requirements. This upfront testing reduces risks and ensures that any issues are identified and addressed before installation, preventing delays and additional costs later in the project.
This blog explores the significance of FAT in the CQV lifecycle, its benefits, how it verifies system performance, and how FAT documentation can be leveraged for qualification purposes.
Table of Contents
1. Introduction3. FAT in the Commissioning, Qualification, and Validation (CQV) Lifecycle 4. How FAT Verifies System Performance 5. FAT Documentation and Its Role in Qualification
6. Best Practices for Effective FAT Execution
7. Conclusion
1. Introduction
Factory Acceptance Testing (FAT) plays a crucial role in the Commissioning, Qualification, and Validation (CQV) lifecycle, especially for industries regulated by stringent quality standards, such as pharmaceutical and biopharmaceutical manufacturing. FAT is performed before equipment is shipped to the installation site, providing an opportunity to verify that the system meets the defined specifications and requirements. This upfront testing reduces risks and ensures that any issues are identified and addressed before installation, preventing delays and additional costs later in the project.
This blog explores the significance of FAT in the CQV lifecycle, its benefits, how it verifies system performance, and how FAT documentation can be leveraged for qualification purposes.
2. Understanding Factory Acceptance Testing (FAT)
FAT is an inspection and testing process performed at the manufacturer’s facility to ensure that equipment functions according to user requirements before it is transported to the final installation site. It is a critical phase in the equipment procurement and validation process, particularly for systems used in regulated industries such as pharmaceuticals.
Key Objectives of FAT
- Ensure that the system or equipment meets the User Requirement Specifications (URS).
- Verify that all functional, operational, and safety requirements are fulfilled.
- Identify and resolve any issues with the equipment or system before shipment.
- Ensure that the vendor's manufacturing and testing processes meet industry standards and Good Engineering Practices (GEP).
3. FAT in the Commissioning, Qualification, and Validation (CQV) Lifecycle
The Commissioning, Qualification, and Validation (CQV) lifecycle is a structured process used to ensure that systems are fit for their intended use, especially in industries where product quality and safety are paramount.
Linking FAT to CQV Phases
FAT occurs at a pivotal point in the CQV lifecycle, between the specification/design phase and on-site commissioning. It is closely linked to both the commissioning and qualification processes:
- Commissioning Phase: FAT is often integrated into the commissioning plan as it is a preliminary test to ensure that equipment functions as expected before installation.
- Qualification Phase: The documentation and results from FAT can be used to support the Installation Qualification (IQ) and Operational Qualification (OQ) phases on-site.
Benefits of FAT in CQV
- Risk Mitigation: FAT identifies issues in a controlled environment, preventing costly delays during on-site installation.
- Efficiency: By resolving problems during FAT, the time required for on-site testing and qualification is reduced.
- Cost Savings: Addressing design and functional discrepancies at the factory level avoids expensive rework and downtime at the installation site.
- Documentation: The detailed records from FAT can be leveraged during the qualification stages, reducing duplication of effort.
4. How FAT Verifies System Performance
During FAT, the system undergoes a series of predefined tests to verify that it meets all necessary functional, operational, and safety requirements. These tests are typically developed based on the User Requirement Specifications (URS), Functional Specifications (FS), and Design Specifications (DS).
Critical Elements Tested in FAT
- Functionality: Ensuring that all components operate as intended.
- Safety: Verifying safety interlocks, alarms, and emergency shut-off features.
- Performance: Assessing performance under various conditions to ensure it meets the defined criteria.
- Compliance: Ensuring adherence to relevant industry standards (e.g., GMP, ISO standards).
Examples of FAT Tests that Integrate with Qualification
FAT tests conducted at the vendor site can directly support the qualification phase, especially when dealing with critical equipment such as vessels. For example, the General Arrangement (GA) drawing of a vessel, which details its dimensions, nozzle positions, and other physical characteristics, is often reviewed during FAT to ensure compliance with design specifications. This review can support Installation Qualification (IQ), as the GA drawing verifies that the vessel’s dimensions and installation points meet the intended design before the equipment is shipped. This eliminates the need for re-measurement during IQ, provided no significant modifications occur during transportation and installation.
- IQ Example: During IQ, the as-built vessel dimensions can be compared directly to the GA drawing approved during FAT, confirming that the vessel’s physical characteristics match the intended design and ensuring proper fit within the facility's layout.
Another example is coverage testing of vessels, where spray balls or cleaning-in-place (CIP) systems are tested at the vendor site to ensure complete coverage of all internal surfaces. During FAT, these systems are tested to confirm they achieve full cleaning coverage, a critical requirement for maintaining sanitary conditions in pharmaceutical and biopharmaceutical manufacturing.
- OQ Example: The coverage testing data from FAT can be reused in Operational Qualification (OQ), where the cleaning system's performance is reverified on-site under actual conditions. By leveraging the results from FAT, only site-specific adjustments, such as different water pressures or flow rates, may need to be tested, reducing the time and effort needed for requalification.
These specific FAT tests provide strong support for IQ and OQ by ensuring that critical aspects like physical compliance and cleaning effectiveness are validated before installation and can be confidently integrated into the qualification phases.
Leveraging Vendor Expertise
Vendors are experts in their systems and equipment, and leveraging their expertise during FAT can help streamline the process. Working closely with vendors allows for:
- Proper test planning and execution.
- Clear understanding of system capabilities and limitations.
- Access to expert knowledge for troubleshooting and resolving issues quickly.
5. FAT Documentation and Its Role in Qualification
FAT produces extensive documentation that provides evidence that the equipment has been tested and is fit for purpose. This documentation is critical during the qualification stages of the CQV process, particularly for Installation Qualification (IQ) and Operational Qualification (OQ).
Types of FAT Documentation
- Test Protocols: Detailed descriptions of the tests performed, including test procedures, acceptance criteria, and results.
- Deviation Reports: Documentation of any discrepancies or deviations encountered during testing and how they were resolved.
- Certificates of Conformance: Verification that the equipment complies with applicable standards and specifications.
- Calibration Reports: Documentation of calibration of key instruments used during FAT.
Using FAT Documentation for Qualification
One of the main advantages of FAT is the ability to use its documentation to support subsequent qualification efforts, reducing redundancy. Documentation from FAT can be leveraged for:
- Installation Qualification (IQ): FAT documentation provides evidence that the equipment was constructed and operates as specified, reducing the need for repeat testing during IQ.
- Operational Qualification (OQ): FAT results showing that the system performs within specified limits can be used as part of OQ, provided that the equipment is installed under similar conditions.
6. Best Practices for Effective FAT Execution
To ensure that FAT is effective and contributes meaningfully to the CQV lifecycle, companies should follow these best practices:
- Develop a Detailed FAT Plan: A well-documented FAT plan outlining the scope, tests, and criteria is essential for ensuring that all necessary aspects of the system are tested.
- Involve Stakeholders: Ensure that key stakeholders, including quality assurance, engineering, and operations, are involved in the FAT process.
- Conduct Pre-FAT Reviews: Reviewing the system’s design, specifications, and URS before FAT can help identify potential issues early and streamline the testing process.
- Document Everything: Comprehensive documentation of test results, deviations, and resolutions is essential for leveraging FAT documentation during the qualification process.
- Focus on Critical Aspects: Prioritize testing of critical system aspects that directly impact product quality and compliance.
7. Conclusion
Factory Acceptance Testing (FAT) is a critical component of the CQV lifecycle, providing an opportunity to verify system performance and address issues before installation. By integrating FAT into the CQV process, companies can reduce risk, save time, and lower costs. Moreover, FAT documentation can be leveraged during the qualification phases, reducing duplication of effort and streamlining the overall validation process.
Implementing best practices during FAT ensures that the system is fit for purpose and meets both regulatory and operational requirements, providing confidence that the system will perform as expected in its final environment. This makes FAT an invaluable tool for ensuring quality, safety, and compliance in pharmaceutical and biopharmaceutical manufacturing.
