Service and projects
FAT (factory acceptance test)
A factory acceptance test (FAT) is, in the EU good manufacturing practice guidelines for medicinal products (EudraLex Volume 4, Annex 15, 2015), the evaluation of equipment at the vendor before delivery; equipment should, if applicable, be confirmed to comply with its user requirements specification or functional specification at the vendor site before installation.
Annex 15 lists FAT and the site acceptance test among the qualification stages of equipment, between design qualification and installation qualification. It says that equipment, especially if it incorporates novel or complex technology, may be evaluated, if applicable, at the vendor prior to delivery, and that, where appropriate and justified, documentation review and some tests could be performed at the FAT without being repeated on site, if it can be shown that transport and installation do not affect functionality. A FAT may be supplemented by a SAT after the equipment is received at the manufacturing site.
UNDP's technical and regulatory requirements for oxygen plants (effective 1 January 2025) state that pre-shipment inspection, performance tests, alarm tests and commissioning reports are required. Ultra Controlo designs and manufactures its systems in Portugal, in its own factories, and the ULTRAOX SC datasheet states that the equipment is parameterised and tested in the factory.
Sources
- European Commission, EudraLex Volume 4, EU Guidelines for Good Manufacturing Practice, Annex 15: Qualification and Validation (30 March 2015), sections 3.1 to 3.7
- UNDP, REQ-OXY-001 v01, Technical and regulatory requirements for oxygen plants (effective 1 January 2025), section 6.2
- Ultra Controlo Corporate Presentation 2026, p. 4
- ULTRAOX SC datasheet, p. 3
Ultra Controlo figures come from its technical datasheets. Third-party facts were read at the source on the date shown.