Factory Acceptance Test in Pharmaceuticals

The pharmaceutical industry has specific requirements when it comes to the equipment used for the production of pharmaceutical forms. This equipment, due to its specificity, is produced accurately in line with the specifications or contractual request (functional requirements document) of a certain drug manufacturer. Before delivery of a final product every purchaser wants to make sure that it is designed, produced and that it operates in an expected way.

Factory acceptance test (FAT) has a very important role in securing product’s quality. The FAT includes conducting a series of tests, which prove that the equipment is designed, executed and works in the agreement and with the requirements of the user. 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. 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 FAT, 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 designer of the machinery.

Procedure of FAT 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. Also, it is necessary that the timetable of performance tests is established, as well as the time of execution.

It is 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 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.

Besides factory acceptance tests, there are some tests that must be performed at the installation site, after the assembly of the equipment. It is possible that the equipment suffers 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 Site acceptance test (SAT). After successfully completing the SAT 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.

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