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Factory Acceptance Test (FAT) in Pharmaceutical

After completing the Design Specification and Design Qualification for new equipment, a user inspection is typically conducted before the delivery to the site. This inspection is referred to as the Factory Acceptance Test (FAT). The manufacturer of a machine will prepare the FAT protocol based on the Design Qualification, as per the built machine specification, calibration certificate, and documents of spare and equipment used on the machine. The manufacturer then sends this protocol to the client/user for review and approval.

The user or client will review and approve the FAT protocol. They will visit the factory of the machine manufacturer to inspect the machine, ready for delivery, in accordance with the effective protocol.

Predefined acceptance criteria for FAT:

FAT is generally the first stage of system testing and should be witnessed by the customer before the agreement for the machine to be delivered to the user site. The manufacturer should ensure that a machine can pass the predefined test Before the witness acceptance testing to minimize the risk of any testing.

During factory acceptance testing, the user should test and verify every component of the machine for operation and functioning as per predefined acceptance criteria.

Predefined Test for FAT:

  • Thorough HMI (operator interface) review – Verify all buttons and sequencing are correct. Review all of the HMI or PLC to understand the way to navigate and run the equipment.
  • Functional Testing – Check each component and instrument to verify everything is running to their setpoints, and every parameter is under limit And found satisfactory.
  • Performance Testing – Run through the mechanical verifications and cross-reference everything with the P&ID, BOM, GA, and Electrical Drawings.
  • Review Operation Codes and Sequencing – Run through every recipe, Operation Codes, and Operation Codes editing and verify that everything is sequencing properly within PLC.
  • Review Alarms and Messages – Execute all alarms and review all information messages on the HMI.
  • Mechanical Verification – Check surface finishes and piping slopes, BOM and P&ID tagging verification, and dimensional check.

Acceptance criteria for FAT (Documentation):

  • Verify a build driving with the machine
  • Calibration of instruments
  • MOC certificate
  • Check the safety control, signal, and critical control points as per DQ.
  • Perform the functional test as per requirement and FAT protocol.
  • Software requirement to be met as per 21CFR part 11.

If the machine complies with the URS, DQ, and acceptance criteria, it is recommended for delivery to the site. The factory acceptance test (FAT) protocol and report shall be reviewed, and approved by the manufacturer and user after completion of FAT and before delivery of the machine.

If the machine does not comply with the acceptance criteria, the modification shall be approved through a change control system or can be accepted with the deviation system. FAT shall be carried out in case of modification. The machine will be delivered to the site after the completion of FAT.

Note: FAT Test Templets will be uploaded here soon…

  • Naresh Bhakar

    Naresh Bhakar is the Founder and Author at Pharmaguddu.com, bringing his extensive expertise in the field of pharmaceuticals to readers worldwide. He has exprience in Pharma manufactring and worked with top Pharmaceuticals. He has rich knowledge and provides valuable insights and data through his articles and content on Pharmaguddu.com. For further inquiries or collaborations, please don't hesitate to reach out via email at [email protected].

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