Site Acceptance Test [SAT]
Site Acceptance Test [SAT] A test conducted at the manufacturer’s site of use, to verify that the system is meets approved specifications.
Pharmaceutical Guideline1 min read

site acceptance test. A test conducted at the manufacturer’s site of use, to verify that the system, equipment or utility, as assembled or partially assembled, meets approved specifications.
If the FAT has already been performed; the site team is aware about the system, equipment or utility hence, the scope of SAT shall be decided considering the outcome of FAT reports
If FAT has not been performed, the site shall consider more checkpoints
The tests, based on principles of quality risk management, may be performed to verify the acceptability of the utility or equipment when it is received at the end-user. This is a site acceptance test (SAT).
The SAT shall includes following points (not limited to…)
- Packing list (the list of items received with traceability)
- Unloading instruction
- Material Safety Data (if applicable)
- Items gross weight, (it will help to arrange the unloading equipment)
- The physical condition of the package (damage during transportation)
- Any missing item as per packing list (also check as per intended use )
- The required documents (Commercial, Technical etc.)
- After Unloading storage of system, equipment or utility components (items)
The results of the tests should be evaluated and the outcome of the acceptability of the utility or equipment should be recorded in the conclusion section of the report for the SAT.
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Periodic review and requalification: Periodic review and requalification shall be carried out to ensure the Utilities and equipment should be maintained
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QAOperational Qualification (OQ): Protocol, Tests & Examples
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