Site Acceptance Test
Although the question came from Japan, my answer is based on GAMP 5 recommendations and therefore applicable to other How to use GAMP areas using GAMP. Factory Acceptance Testing (FAT) is performed for systems that comprise novel or complex technology. (We have an infographic that discusses the system categorizations defined by ISPE, which is worth a look to make the following information clearer if you are not familiar with those.)
The ISPE’s GAMP 5 guidance tells us that in a given project, there may be some pre-delivery testing that can include Factory Acceptance Test. This testing is performed at the manufacturer’s factory. This testing requires that all system components be assembled and tested to show that the system functions as expected.
However, GAMP tells us this type of testing is not needed for GAMP Category 3 or 4 systems unless they are brand new and extremely complex. Whether FAT is needed for Category 5 systems that are dependent on the system type, novelty, and complexity.
Factory Acceptance Training is not performed for a Vaisala monitoring system because its components are separate, off-the-shelf products, and they are neither new nor complex. Also, we can’t assemble your monitoring system at our factory, so there is really nothing to test. The tests that ensure the system performs as expected are covered by the Installation Qualification and Operation Qualification protocols.
Site Acceptance Test (SAT) should be performed if such tests are included in your quality system requirements. ISPE GAMP 5 defines SAT as a process that shows the system to be working as expected in its operational environment. The tests show whether the system interacts correctly with all other systems at the site. For example, in SAT you compare the delivery to your purchase order to see that you have received the correct software and hardware components.
In addition, SAT can also contain documentation or verification of any configurations you’ve done. If you have a Configuration Specification (a type of Design Specification that includes items such as system user names, phone numbers, email addresses, threshold limits, delays and comments related to alarms etc.), you verify that your system is configured correctly according to your requirements. Obviously, SAT cannot be performed without knowing your specific system configuration requirements.
Going back to the original question, which was asked by a Japanese customer, per Japanese GAMP guidelines, design specifications and acceptance tests are not required for a Category 3 system. Refer to Appendix 2 of the Japanese guideline: here is the English translation provided for reference only from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
