Conduct FAT and SAT for All New GMP Equipment to Ensure Compliance

Conduct FAT and SAT for New Equipment Before GMP Validation

Remember: Always perform Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new GMP equipment — this ensures compliance, reliability, and readiness for qualification.

Why This Matters in GMP

FAT and SAT are essential steps in equipment procurement and commissioning within GMP environments. FAT is conducted at the vendor’s site to verify that the equipment performs according to the agreed specifications before shipment. SAT is conducted at the user’s site to ensure that the installed equipment functions correctly under actual operational conditions. Skipping or inadequately performing these tests can lead to installation delays, performance failures, and non-compliance with validation expectations.

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For example, if an autoclave is received and installed without FAT/SAT, latent issues such as incorrect cycle programming, steam pressure inconsistencies, or sensor calibration failures may go unnoticed until validation or worse, during production. Conducting FAT/SAT reduces risk, identifies non-conformances early, and provides documented evidence of system readiness for qualification (IQ/OQ/PQ).

Regulatory and Compliance Implications

21 CFR Part 211.63 requires equipment to be suitable for its intended use and maintained accordingly. EU GMP Annex 15 outlines FAT and SAT as part of

the overall equipment qualification lifecycle. WHO GMP guidelines emphasize documented verification of equipment performance before validation. Regulators consider FAT/SAT as a best practice to ensure that systems are installed and operate correctly before validation investment begins.

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Auditors will review FAT/SAT reports, deviation records, user requirement alignment, and supplier qualification documents. Omission of FAT/SAT or inadequate documentation may result in findings under equipment suitability, validation failure, and project control deficiencies.

Implementation Best Practices

Include FAT and SAT as defined milestones in the equipment procurement SOP. Develop test protocols that verify mechanical, electrical, software, and functional specifications. Conduct FAT with multidisciplinary teams (Engineering, QA, User) and include pre-shipment punch point closure. Ensure SAT includes utility connection, environmental integration, and initial calibration check at the manufacturing site.

Document all test results, observations, and deviations. Ensure that discrepancies are resolved before proceeding to IQ/OQ/PQ. Use standardized templates and approval formats. Link FAT/SAT outcomes to equipment validation files and user requirement specifications (URS).

Also Read: Never Skip Manufacturing Steps to Save Time in GMP Operations

Regulatory References

– 21 CFR Part 211.63 – Equipment suitability and maintenance
– EU GMP Annex 15 – Qualification and Validation
– WHO TRS 1019, Annex 3 – Equipment installation and qualification
– ISPE Baseline Guide Vol. 5 – Commissioning and Qualification