SAT is an inspection at the user’s site after machine/instrument delivery. opposite to SAT, the Factory acceptance test is a Manufacturer site inspection by the user. site acceptance test in pharmaceuticals is done to verify the functioning, operation, and parameters along with manufacturere repersentative.
Site Acceptance Protocol
Site acceptance test protocol is prepared by the machine manufacturer and reviewed by the user and manufacturer, after that, it will be finalized.
Procedure for Site Acceptance Test
- The manufacturer inspects the size to check the facilities likes, service line, flooring, power, air, and vacuum are available.
- The machine will be reviewed by the user as per the SOP of receipt.
- Manufacturing will send engineering to the user site to install the machine
- The machine is moved out of packing then the machine will be inspected for any damage during transport handling as well as during loading and unloading. at this stage, the machine will be checked properly to check for any wear and tear during the transport service.
- Check spare parts tools as per the packaging list records observations. basically, it checks to ensure all the spare parts are available or not
- check the documents such as manuals, excise, and transport documents by users at the time of delivery.
- hand over these documents to the concerned departments.
- carry out the cleaning and sanitization before it transfers to the location to prevent any types of microbes and bacterial growth.
- wrap the machine with polyethylene and transfer it to the required area,
- Check the availability of power, water supply, air, and service lines.
Related: User Requirement specification