Factory Acceptance Test (FAT) in Pharma: Checklist & Scope

Factory Acceptance Test (FAT),

A test conducted, usually at the vendor’s premises, to verify that the system, equipment or utility, as assembled or partially assembled, meets approved specifications.

Where a utility or equipment is assembled, or partially assembled at a site other than that of the purchaser or end-user, testing and verification may be done, based on principles of quality risk management, to ensure that it is appropriate, as described in the URS, and ready for dispatch.

The checks and tests conducted during the factory acceptance test (FAT) should be recorded.

The acceptability of the assembly and overall status of the utility or equipment should be described in the conclusion of the report for the FAT, prior to shipment.

User requirement specifications (URS), functional specifications (FS), and design specifications (DS) are all incorporated into the equipment design and manufacture

The FAT is performed in production-like conditions at the manufacturer’s site, where testing equipment, utilities, and trained personnel are available to ensure that the equipment functions as designed.

It is also easier and less expensive to correct issues or implement design changes at the manufacturer’s facility.

A well-planned and well-executed FAT can lead to an easy transition to site acceptance testing (SAT), qualification, and continual monitoring of the equipment after delivery.

Before starting FAT; the Protocol shall be prepared considering the User Requirements Specification (URS), Design Qualification (DQ)

FAT Planning

This is the first step in which The scope of the FAT shall be defined.

The Prerequisite for the FAT shall be checked as per the pre-defined FAT Protocol

Documents

The relevant documents like…

1. Drawings (GA, P&ID, etc.)
2. User Manual of the Equipment
3. Maintenance manual of the Equipment
4. FAT Checklist
5. Calibration Certificate
6. Bought out item Certificate
7. Any instrumentation used to record data during the test will be verified to be within the calibration date as required by manufacturer or customer specifications, prior to the test.

The documents verification is an essential part of FAT

Testig / Tryal of Equipment

The Equipment shall be verified as per approved drawings (GA, P&ID, etc.)

The Equipment shall be operated as per the User Manual provided by the manufacturer

The test result/operation of the Equipment shall be verified and recorded in the FAT report / Data sheet

The results/observations shall meet the pre-defined approved acceptance criteria as per FAT protocol.

The unusual observation shall be recorded in the report and the Corrective Action and Preventive Action (CAPA) Shall be determined.