In the highly regulated pharmaceutical industry, ensuring that equipment functions as expected is essential to maintaining product quality and adhering to Good Manufacturing Practices (GMP). To achieve this, equipment must undergo various qualification processes. Two critical aspects of this qualification are Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT). Both FAT and SAT are vital to the validation of pharmaceutical equipment, ensuring that it meets both design and operational specifications before and after installation. This blog post will explore FAT and SAT, their processes, similarities, differences, and the documentation required for each.
What is FAT?
Factory Acceptance Testing (FAT) is a process performed at the manufacturer’s facility to ensure that the equipment being purchased or custom-built for a pharmaceutical company operates according to its design specifications before it is shipped. FAT is a comprehensive inspection and testing procedure conducted in a controlled environment, usually witnessed by both the vendor and the client, to verify that the equipment functions correctly under factory conditions.
During FAT, all aspects of the equipment are thoroughly tested, including mechanical, electrical, and software components. FAT serves as a final quality check to confirm that the equipment performs as expected before it leaves the manufacturer’s premises. If any issues arise during FAT, they can be addressed immediately by the manufacturer, minimizing the risk of problems once the equipment reaches the client’s site.
Key components of FAT include:
- Verification of design specifications
- Functional testing of the equipment
- Software testing and integration with other systems
- Verification of operational safety and adherence to regulatory requirements
FAT is critical in ensuring that the equipment is fit for purpose and meets all regulatory and operational standards before it is delivered to the client.
What is SAT?
Site Acceptance Testing (SAT) is the next stage of equipment validation and is conducted at the client’s site after the equipment has been installed. SAT involves testing the equipment under real-world operating conditions to ensure that it integrates properly with other systems and performs as expected within the specific operational environment.
The goal of SAT is to verify that the equipment functions correctly once installed, connected, and integrated with other equipment and systems in the production facility. It also confirms that the installation was completed correctly, and that the equipment meets all predefined requirements, including those identified during the Factory Acceptance Test (FAT).
Key components of SAT include:
- Verification of installation (Installation Qualification or IQ)
- Functional testing under actual operating conditions
- Performance testing to ensure the equipment operates within the required specifications (Performance Qualification or PQ)
- Testing of equipment interfaces and integration with other systems
- Confirmation that all operational safety measures are in place
SAT is often conducted in collaboration with the equipment supplier, facility engineers, and quality assurance teams to ensure that all relevant stakeholders are confident in the equipment’s performance.
What Are the Similarities Between FAT and SAT?
FAT and SAT share several similarities, as both are critical to the equipment qualification process and aim to ensure that the equipment performs according to specifications. The main similarities include:
- Quality Assurance: Both FAT and SAT are designed to ensure that equipment meets predefined quality standards and regulatory requirements before it is put into use.
- Functional Testing: Both FAT and SAT involve rigorous functional testing to verify that the equipment operates as intended. While FAT is conducted under factory conditions, SAT involves testing under real-world conditions at the client’s site.
- Documentation: Both processes require thorough documentation of test results, including any deviations and corrective actions taken. This documentation is essential for regulatory compliance and quality assurance purposes.
- Stakeholder Involvement: Both FAT and SAT require collaboration between the equipment manufacturer, the client, and other relevant parties, such as engineers and quality assurance personnel, to ensure that the equipment is fully tested and validated.
- Compliance with Regulatory Standards: FAT and SAT are both conducted to ensure that the equipment complies with industry-specific regulatory requirements, such as those set by the FDA, EMA, or other regulatory bodies.
What Are the Differences Between FAT and SAT?
Despite their similarities, there are also important differences between FAT and SAT, primarily in terms of where and how the testing is conducted.
- FAT: Conducted at the manufacturer’s facility, typically in a controlled environment where the equipment is built or assembled.
- SAT: Conducted at the client’s site, after the equipment has been delivered and installed.
- FAT: Focuses on ensuring that the equipment functions as per design specifications and passes all functional and safety tests before shipment.
- SAT: Focuses on verifying that the equipment integrates properly with other systems and performs correctly under actual operating conditions.
- FAT: Performed under controlled, factory-specific conditions, typically without the influence of external environmental or operational factors.
- SAT: Performed in the actual operating environment, where real-world conditions, such as temperature, humidity, and system integration, may affect equipment performance.
- FAT: Primarily focuses on ensuring that the equipment meets design and functional requirements.
- SAT: Expands the scope to include the installation and operational performance in the client’s production environment.
- FAT: Conducted before shipment, often allowing manufacturers to fix any issues before delivery.
- SAT: Conducted after installation, ensuring that the equipment works correctly in its final operational context.
The FAT and SAT Process
Both FAT and SAT follow a structured process to ensure that equipment meets all the necessary operational and regulatory requirements. Below is an outline of the key steps involved in each process.
FAT Process:
- Preparation: The manufacturer prepares the equipment for testing and develops an FAT protocol that outlines the tests to be conducted, acceptance criteria, and any specific operational requirements.
- Testing: The equipment is tested according to the FAT protocol, covering aspects such as mechanical, electrical, and software functions. Any deviations or issues are recorded.
- Results Review: After the testing is complete, the results are reviewed by both the manufacturer and the client to ensure the equipment meets all design specifications.
- Resolution of Issues: If any issues are identified, corrective actions are taken by the manufacturer to resolve them before the equipment is shipped.
- FAT Report: A final FAT report is generated, documenting the test results, any deviations, corrective actions, and the overall conclusion of whether the equipment is ready for shipment.
SAT Process:
- Installation: The equipment is installed at the client’s site, typically by the manufacturer’s technicians, to ensure that it is set up according to the installation specifications.
- Development of SAT Protocol: Similar to FAT, a detailed SAT protocol is developed, outlining the specific tests and operational conditions to be verified.
- Testing: The equipment is tested under real-world operating conditions to ensure that it performs as required. This includes verifying its integration with other systems and interfaces.
- Results Review: The results of the SAT are reviewed by both the client and the equipment supplier to confirm that the equipment is functioning correctly.
- Resolution of Issues: If any problems are identified, they are addressed on-site by the manufacturer or installation team.
- SAT Report: A final SAT report is generated, documenting the test results, any deviations, corrective actions, and the conclusion regarding whether the equipment is operationally qualified for use.
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Both FAT and SAT require extensive documentation to ensure compliance with regulatory requirements and to serve as a record of the qualification process.
FAT Documentation:
- FAT Protocol: A document outlining the specific tests to be conducted during FAT, including acceptance criteria and test methods.
- Test Data: A record of all the test results, including any deviations or issues encountered during FAT.
- Corrective Actions: Documentation of any corrective actions taken to address issues identified during testing.
- FAT Report: A comprehensive report summarizing the FAT process, including test results, deviations, corrective actions, and the final conclusion.
SAT Documentation:
- SAT Protocol: A document detailing the tests to be conducted during SAT, the specific operating conditions to be tested, and the acceptance criteria.
- Test Data: A record of all the test results collected during SAT, including data on system integration and operational performance.
- Corrective Actions: Documentation of any corrective actions taken to resolve issues encountered during testing.
- SAT Report: A final report summarizing the SAT process, including test results, any deviations, corrective actions, and the conclusion.
Conclusion
Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) are critical components of the equipment qualification process in the pharmaceutical industry. Both FAT and SAT are designed to ensure that equipment functions according to specifications and regulatory requirements before it is put into use. While FAT focuses on verifying the equipment’s performance at the manufacturer’s site, SAT confirms its operational functionality after installation at the client’s site. By thoroughly documenting and executing these processes, pharmaceutical companies can ensure that their equipment is fully qualified, compliant, and ready for production.
References
FDA Guidance on Equipment Qualification
FDA Process Validation: General Principles and PracticesInternational Society for Pharmaceutical Engineering (ISPE)
ISPE Guidance on Commissioning and QualificationGMP Requirements for FAT and SAT
European Medicines Agency – Good Manufacturing PracticesICH Q7 Guidelines on Equipment Qualification
ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Mehrnaz Bozorgian
Mehrnaz Bozorgian, a Quality Assurance Specialist at Zamann Pharma Support, brings over 7 years of experience in international pharmaceutical compliance and related quality management systems. Specializing in audit and inspection topics, Mehrnaz's current goal is to focus more on Audit and Supplier Management to enhance the Zamann Service portfolio in this regard. Outside of work, she is an accomplished athlete holding a third-degree black belt in Taekwondo. With a passion for continuous improvement, Mehrnaz is an avid reader who enjoys exploring motivational and lifestyle enhancement resources. Connect with Mehrnaz on LinkedIn for insights into quality assurance and auditing.
