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How To Create A Factory Acceptance Test FAT Protocol

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Before pharmaceutical shipping equipment, it is imperative that the vendor carries out a Factory Acceptance Test or FAT in order to prevent any problems occurring during the product installation. Below is a sample of what should be indicated in the FAT protocol document.

Objective/Purpose

Indicate the objective of installing the equipment or the purpose of the equipment. This section should detail the specifications, design and the expected performance of the equipment.

Scope

The scope should indicate the whole range of equipment that the FAT governs. For example: “This FAT governs all equipment or devices manufactured by Company XY.”

Method

  • List all of the systematic processes that the equipment should perform during operation.
  • Indicate the steps to be taken if any deviation or change is observed during and after the process.
  • Indicate all the documents that should be checked.

Credentials

Write the steps to be taken for documentation during the Factory Acceptance Test.

Criteria

  • The equipment and its accessories must be manufactured as per specification.
  • The equipment should conform to the required pre-designed parameter.

Verification Checklist

This should include all the tests and parameters that were conducted and should be verified during the FAT.

  • Make
  • Model
  • Capacity
  • Design
  • Equipment parts, design, specification
  • MOC
  • Quantity or number of parts
  • Control Panel – auto, manual, emergency
  • PLC panel – make, quantity, model
  • Temperature sensor – make , model, quantity
  • RH sensors
  • Safety Features – ex: emergency stops, guide on moving parts
  • Documents – bill of materials, materials of construction certificate, other certificate, warranties and manuals

Observed Deviations

Include the changes that were observed during the verification test and the investigation process and the actions taken to correct the deviations and whether the changes are acceptable or not.

Conclusions

Include the overall results of the FAT protocol, whether the equipment passed or failed the test.

LFA would be happy to conduct a Factory Acceptance Test or any other procedure that you require prior to your purchase or installation of tablet press or pill press. Our team has a broad understanding of ISO 22000 TS 22002, GMP, The Orange Guide as well as the requirements of both the MHRA and the FDA. If you are interested in any of our products and have specific requirements, do please contact to find out how we can help you.

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