Dear All,
I want to know the difference between SAT and IQ/OQ ? if suppose some test performed during SAT is really repeat in IQ/OQ or we can give the SAT reference in IQ /OQ.
Regrds
Himanshu C
In my experience when a test is performed in the SAT it is not repeated in the IQ/OQ.
I would imagine referencing the test in the IQ or OQ is fine.
As long as everything is tested somewhere your RTM should show this and cover you for any nasty audit questions
You may want to test some things in SAT that are outside the IQ/OQ - that’s one difference. The other is that SAT is usually a commercially driven requirement while IQ/OQ is primarily a regulatory driven one - this may determine your approval cycle for documents and what type of documents you produce. For example, IQ and OQ are usually a combination of approved protocol (before the work) and approved report (afterwards). SAT might be a non-approved protocol and approved report - with different approval to IQ/OQ.
As an example: we require that equipment can be changed over from one product to another within a 15 minute timescale. We will test this during SAT, and our production managers and engineers will be interested in the results. We will not pay our suppliers the final installment until this requirement is satisfied. Our QA colleagues are not interested in how long or short the changeover time is - so they don’t see this work or report. They are interested in whether the change over can be accomplished without compromising the equipment’s performance with respect to the product.
If a test is done which would satisfy both the SAT and the IQ/OQ, we would normally perform that in the IQ/OQ itself, then any SAT document refer to the IQ/OQ rather than the other way round. That way we know the tests have the proper approval and oversight for IQ/OQ, and we can present only the IQ/OQ to an auditor without them having sight of the SAT.
Can any one please give a complete example of SAT and FAT for any machine. For example a Blister machine.
This is a Link to the ISPE JETT SIG. They have posted draft URS’s for various types of equpment or systems. They did a Filler where they drafted all of the life cycle documents. The Test Map has examples of what is tested in each stage of the life cycle.
Dear Shubhendu SC,
A typical validation life cycle is described in ISPE’s commissioning & qualification chapter. I may interpret it as follow. In broad view FAT & SAT are integral part of IQ/OQ with regard to technical & gmp contents therein. In other word we can segregate it as FAT-IQ, FAT-OQ & SAT-IQ, SAT-OQ. Further, FAT & SAT shall combine form IQ & OQ.
Example wrt to Blister packing m/c-
In approved FAT protocol component, drawing & MOC verification is included. After receiving the m/c at site, suppose utility, safety, calibration verification, test to check the suitability for particular tablet size were included in approved IQ/OQ protocol but blister pack leak test or test related to batch code print & register was inadvertently skipped from IQ/OQ protocol. Now this test can be executed on site & document it as SAT & attached the same to qualification package as addendum. In short FAT + SAT= IQ/OQ.
Test carried out during FAT need not be repeated during SAT/IQ/OQ unless there is impact of transportation on equipment.
Regards
Ravi Dhanbhar
The key point to remember when leveraging FAT and SAT protocols for use in IQ and OQ is that you need to spell it out in the Validation Plan. Get the Quality buy in early. You need to test thoroughly but you only need to test it once. There are many ways to implement this strategy, but the key is to have it in your plan up front.
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I agree entirely with RR410.
Also a lot of companies are using tests from the SATs to leverage into IQ and/or OQ.
Please be aware that if you quote a document where these tests have been leveraged from then QA have a right to scrutinze the aforementioned documents.
Agree. If QA got involved in SAT and have approval signature, SAT testings can be leveraged in IQ/OQ
This depends on your QA group. Some QA groups are fine with leveraging, and others have found that leveraging is messy, and requires additional defense and documentation. There are a few tests that I always like to leverage such as alarm testing, software and firmware verification, materials of construction - or any items which cannot or do not change between FAT/SAT and IOQ.
The reason to do an SAT and FAT is to shake the issues out of the system. The reason to do qualification is to ensure that everything is as expected. I’ve done FATs where too many things need to be corrected, and thus negates the option to do a leveraged IOQ. But at other times the FAT is easily leveraged. It depends on how ready the system was for the FAT.