Good Automated Manufacturing Practice (GAMP) – Test Example
Testing Process Automation Systems
This article cover the third part of our Good Automated Manufacturing Practice (GAMP) test example. This part will cover the typical test phases for Factory Acceptance Test – FAT, Site Acceptance Test – SAT / Installation Qualification – IQ, Operation Qualification – OQ and Performance Qualification – PQ
Typical Test Phases – GAMP – Test Example
Typical test phases for a complex process automation system. This example assumes that the system is configured by a Supplier and delivered to site after a FAT. Test system can also be configured by the system integrator or by the User. In this case, the same coverage is required, but the test phasing and location may be different.
The User and Supplier should work together to develop an overall approach to testing that reflects the risk assessment output and ensures adequate test coverage of the functionality, whilst avoiding unnecessary repeated tests.
Factory Acceptance Test – FAT
Done at the Supplier's premises after Supplier's integration testing, and before the system is released for delivery to the User's site
The required coverage should reflect the relative risk priority associated with the system element under test. This coverage can increase if problem are found within the initial sample.
In determining the required coverage, the User needs to base decisions on the risk assessment output taking into account both the potential effect on product quality and safety resulting from the process, and the intrinsic risk likelihood associated with the method of implementation.
Before performing risk assessment to decide on the required coverage, the User should review the supplier's internal tests to confirm that they are adequately documented.
Site Acceptance Test – SAT / Installation Qualification – IQ
Done at the User's premises after installation of the system on site
:The required coverage should include
Checking that the full system, including HW, SW backups, and documentation has been delivered to site in a condition suitable to its intended purpose
Checking that the site environment suits the specification of the installed equipment: temperature, humidity, pressure, dust, vibration, interference, etc
Checking that the system has been correctly installed.
Demonstration the system still operates as it was when accepted during the FAT, typically by re-recording system components and versions, and by re-repeating a small sample of FATs on site
Testing any elements which could be adequately tested in the FAT environment, typically interfaces to other equipment, networks, etc
Re-testing, following remedial action on any element subject to conditional release at the end of the FAT
Operation Qualification – OQ and Performance Qualification – PQ
Done at the User's premises after SAT/IQ
If a system has been fully tested in the FAT, after successful completion of the IQ (along with any additional field functional tests and calibrations), the system is treated as an integrated part of the process equipment qualification. This should ensure that the full system, procedures and trained personnel are ready for production.
End of GAMP – Test Example – part 3.
