FAT = Factory Acceptance Test
Testing of equipment and relevant documentation at the vendor’s work shops against the requirements of an approved test protocol
SAT = Site Acceptance Test
Testing of equipment and relevant documentation at the site of use of the equipment against the requirements of an approved test protocol.
EU-GMP-Guide Annex 15
Factory acceptance testing (FAT)/ Site acceptance testing(SAT)
3.4. Equipment, especially if incorporating novel or complex technology, may beevaluated,ifapplicable, at the vendor prior to delivery.
3.5. Prior to installation, equipment should be confirmed to comply with the URS/
functional specification at the vendor site, if applicable.
What does this mean?
FAT is not a general requirement, not required forsmall,standard equipment equipment that cannot be readily installed at the vendor’s site (e.g.HVAC-Systems
When should FATs be done?
for complex equipment equipment with new technology. If transportation is important, e.g. from Europe to Asia!when installation on site is complicated and equipment has to go back to the vendor when it fails.
Factory acceptance testing(FAT)/ Site acceptance testing(SAT)
3.6. Where appropriate and justified, documentation review and some tests could be performed at the FAT or other stages without the need to repeat on site at 1Q/0Q if itcan be shown that the functionality is not affected by the transport and installation.
3.7. FAT may be supplemented by the execution of a SAT following the receipt of equipment at the manufacturing site.
What does this mean?
When an FAT is performed, tests do not have to be repeated for IQ and0Q,if transport and installation did not have a negative impact tests are performed and documented in a GMP- compliant manner supervision by the qualification team SAT should be done after installation on site .
Remark: This is normally when the supplier gets paid, however.the contract should include that final payment is done after successful OQ(PQ)testing.
