Factory Acceptance Test - FAT : Pharmaceutical Guidelines

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Factory Acceptance Test - FAT

Factory acceptance test FAT is important for equipment because It helps to identify the problems with the equipment and correct them prior to shipping.
Any equipment that is being intended to be used in producing various products has to meet certain specifications before it is delivered to a purchaser and installed. The equipment has to undergo what is called the Factory Acceptance Test (FAT) so as to ensure its proven quality and compliance. These tests play a vital role in ensuring guaranteed quality product.

The Factory Acceptance Testing includes conducting a series of tests, which prove that the equipment is designed, executed and works in the agreement and according to the user's requirements. The test may include performance, physical or chemical investigation; and is performed at the site of the manufacturer of the equipment. It's very important that the testing is approached seriously and prepared.

Factory Acceptance Test
Majority of the successful corporations do not allow delivery of the product without prior testing or the tests performed by automatic systems. Carrying out these tests is a big turning point in each manufacturing project.

Therefore, during the execution of the Factory Acceptance Testing, it's very important that the project leader or the owner of the equipment being tested, are present. Sometimes it's needed that a third party is also present, such as the designer of the machinery.

The procedure of the Factory Acceptance Test must be prepared before the testing and also presented to the equipment owner at least two weeks before the execution of FAT, who then authorizes the process. Moreover, the contractor of the tests will request particular items, for instance finished factory acceptance test protocol, standard operating procedures (SOP), utilization and servicing guides, documentation for user training, instructions for calibrating instruments, certificates of materials and lists of data can, data on qualification of equipment, system scheme, a list the referenced replacement parts etc.

It's advisable to come up with a timetable of the performance tests, and also the time of execution. It's also advisable to test the equipment before the execution of FAT, to save time and unnecessary expenses in case the equipment proves inadequate performance during the tests.

In this case, it is necessary to perform repairs of equipment and then re-testing. The protocol on the previous tests performed and factory acceptance test report should also be supplied in the documentation. If the product conforms to the specification, that is equipment meets the expectations of FAT, it can be delivered to the requester and installed or tested on the site of its use.
Related: How to Write a FAT Protocol?

Besides factory acceptance tests, there are some tests that must be performed at the installation site, after the assembly of the equipment. It's probably the equipment suffered damage during assembly, transport and editing at the customer's / user's location. Therefore, these tests are performed to prove that it functions properly in its operating environment. The tests are performed on the location of the user of the equipment, after its installation and connection with all auxiliary systems.

These tests are called the Site Acceptance Test (SAT). After successfully completing the SAT, the machine can be qualified (the process of proving that the subject equipment or system is working properly and continuously produce the expected results) and put into service.

Importance of Factory Acceptance Test (FAT)
FAT is beneficial for the manufacturer, buyer, and the endpoint user. It is the very cost effective way to fix the errors in the machine. It helps the manufacturer to keep his project running within budget. It is good to rectify all the issues with the machine at the manufacturer site than at the owner site. And the most important is that safety of your employees is your topmost priority, a faulty equipment may cause loss to the buyer as well as the manufacturer. FAT also establish the point where the error (site of error) in the equipment was done.
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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1 comment: Post Yours! Read Comment Policy ▼

  1. Completely agree with the FAT and SAT. It is good way to avoid the problems before dairy use. If no such test, there will be difficult to repair after shipment. The cost will be high by business tirp to another place or country.

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