What is a FAT

A FAT or Factory Acceptance Test is usually preformed at the vendor prior to shipping to a client. The
vendor tests the system in accordance with the clients approved test plans and specifications to show
that system is at a point to be installed and tested on site.

It’s an essential aspect of the whole system lifecycle and should be performed by experienced
personnel. Time spent doing a proper FAT will lead to fewer problems when the equipment is installed
on your site.

ISPE verdict:

The partial commissioning and qualification of equipment and/or systems prior to their shipment from
the fabricator’s site.

Publication Source: ISPE Biopharmaceutical Manufacturing Facilities Baseline® Guide

GAMP verdict:

Factory Acceptance Test (FAT): (IEEE) An Acceptance Test in the Supplier’s factory, usually involving
the Customer.

Publication Source: GAMP 4, Good Automated Manufacturing Practice Guide for Validation of
Automated Systems.

On acceptance of a FAT some items to look out for include:

 Performed FAT Protocol
 Maintenance and User’s manual
 Recommended spare parts list
 Certificate of compliance
 As built technical drawings (electrical, mechanical, pneumatic & process schemes)
 Materials certificates/data sheets
 Main equipments data sheets
 Instruments calibration certificates
 Welding Processes qualification
What is a SAT
A SAT is a Site Acceptance Test the system is tested in accordance to client approved test plans and
specifications to show the system is installed properly and interfaces with other systems and
peripherals in its working environment.

ISPE verdict:

Inspection and /or dynamic testing of the systems or major system components to support the
qualification of an equipment system conducted and documented at the manufacturing site.

Publication Source: ISPE Commissioning and Qualification Baseline® Guide (March 2001)

Below is a list of some items that should be considered when performing a SAT:
 Finishing Visual check
 Main components visual check
 Internal box pressure and ventilation setting
 Utilities functionality and setting check
 Functionality/Interlocks Verification (Mechanical & Software)
 Safety devices and interlocks check
 Operator’s training