{"id":35599,"date":"2015-06-08T12:31:18","date_gmt":"2015-06-08T09:31:18","guid":{"rendered":"https:\/\/smartlogic.co.il\/?p=35599"},"modified":"2015-06-08T12:31:18","modified_gmt":"2015-06-08T09:31:18","slug":"%d7%95%d7%9c%d7%99%d7%93%d7%a6%d7%99%d7%94-good-automated-manufacturing-practice-gamp-test-example-gamp-test-example-part-3","status":"publish","type":"post","link":"https:\/\/smartlogic.co.il\/staging_new\/%d7%95%d7%9c%d7%99%d7%93%d7%a6%d7%99%d7%94-good-automated-manufacturing-practice-gamp-test-example-gamp-test-example-part-3\/","title":{"rendered":"\u05d5\u05dc\u05d9\u05d3\u05e6\u05d9\u05d4 – GAMP – Test Example – part 3"},"content":{"rendered":"

Good Automated Manufacturing Practice (GAMP) – Test Example<\/h2>\n

Testing Process Automation Systems<\/h2>\n

This article cover \u00a0the third\u00a0part of \u00a0our \u00a0Good Automated Manufacturing Practice (GAMP)\u00a0test example<\/a>. This part will cover \u00a0the typical test phases for Factory Acceptance Test –\u00a0FAT<\/strong>,\u00a0Site Acceptance Test –\u00a0SAT<\/strong> \/ Installation Qualification – IQ,\u00a0<\/strong>Operation Qualification – OQ<\/strong> and Performance Qualification –\u00a0PQ<\/strong><\/p>\n

Typical Test Phases – GAMP – Test Example<\/h2>\n

\u00a0Typical 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.<\/p>\n

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.<\/p>\n

Factory Acceptance Test –\u00a0FAT<\/strong><\/h3>\n

Done at the Supplier's premises\u00a0after Supplier's integration testing, and before the system is released for delivery to the User's site<\/p>\n

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.<\/p>\n

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.<\/p>\n

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.<\/p>\n

Site Acceptance Test –\u00a0SAT \/ Installation Qualification – IQ<\/a><\/strong><\/h3>\n

Done at the User's premises\u00a0after installation of the system on site<\/p>\n

:The required coverage should include<\/p>\n

Checking that the full system, including HW, SW<\/a> backups, and documentation has been delivered to site in a condition suitable to its intended purpose<\/p>\n

Checking that the site environment suits the specification of the installed equipment:\u00a0temperature, humidity, pressure, dust, vibration, interference, etc<\/p>\n

Checking that the system has been correctly installed.<\/p>\n

Demonstration the system still operates as it was when accepted during the FAT,\u00a0typically by re-recording system components and versions, and by re-repeating a small sample of FATs on site<\/p>\n

Testing any elements which could be adequately tested in the FAT environment,\u00a0typically interfaces to other equipment, networks, etc<\/p>\n

Re-testing, following remedial action on any element subject to conditional release at the end of the FAT<\/p>\n

Operation Qualification –\u00a0OQ and Performance Qualification –\u00a0PQ<\/strong><\/h3>\n

Done at the User's premises after SAT\/IQ<\/p>\n

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.<\/p>\n

End of\u00a0GAMP – Test Example – part 3.<\/strong><\/h2>\n

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