Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Japan & GAMP for Monitoring Systems

Recently our Regulatory Expert  gave a training session on Annex 15 in Japan and was asked this question:
"Regarding qualifying environments for compliance with Annex 15, we understand that FAT and SAT should be done if required by our products or processes. Under what circumstances do environmental monitoring systems require FAT and SAT?"

Answer:

Although the question came from Japan, my answer is based on GAMP 5 recommendations and therefore applicable to other 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 Testing. 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 Testing (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):
 

Tentative Translation August 17, 2011, Ministry of Health, Labour and Welfare

Guideline on Management of Computerized Systems for Marketing Authorization Holders and Manufacturers of Drugs and Quasi-drugs

Additionally, we recommend that you document configurations as you create them in order to get an overview of how you are configuring your system. By documenting your configurations, you ensure that you have a record to check for changes later on if the system changes.

To ensure we have a good understanding, refer also to the EU GMP Annex 15 on Qualification and Validation as it outlines FAT and SAT. (This guidance has been in operation since October 2015)

Factory acceptance testing (FAT) /Site acceptance testing (SAT)

3.4. Equipment, especially if incorporating novel or complex technology, may be evaluated, if applicable, at the vendor prior to delivery.

3.5. Prior to installation, equipment should be confirmed to comply with the URS/functional specification at the vendor site, if applicable.

3.6. Where appropriate and justified, documentation review and some tests could be performed at the FAT or other stages without the need to repeat on site at IQ/OQ

if it can be shown that the functionality is not affected by the transport and installation.

3.7. FAT may be supplemented by the execution of a SAT following the receipt of equipment at the manufacturing site.

As always, we appreciate your questions and comments in the fields below. And feel free to email if you have further questions!