Please share your words on FAT/SAT/UAT and IQ/OQ/PQ

GOOD DOCUMENTATION PRACTICE (GDocP) FAT AND SAT (FACTORY ACCEPTANCE TESTS AND SITE
1

I want to know the order of FAT/SAT and UAT.

And what is the relation between FAT/SAT/UAT and IQ/OQ/PQ?

Regards
Satya

2

FAT = Factory Acceptance Test, always comes before SAT = Site Acceptance Test since you’re not going to send equipment back to the factory after it’s been delivered typically.

UAT = User-Acceptance Test usually applies to software.

FAT, SAT, and UAT typically occur prior to IQ, OQ, and PQ, but in my opinion, FAT, SAT, and UAT may be leveraged for IQ, OQ, and even some cases PQ provided that:

  1. FAT, SAT, UAT protocols were pre-approved by the owner’s Quality Assurance department prior to test execution
  2. Executers followed owner’s SOPs, especially Good Documentation Practices (GDP) SOPs
  3. Any critical instruments and test instruments were calibrated prior to use
  4. The FAT, SAT, or UAT test to be leveraged meets the intent and detail of the IQ, OQ, or PQ test

I’d also like to make sure all test executors have some kind of training record on file with the owner, to prove to an auditor that they had the requisite experience and knowledge to be performing the test.

Hope this helps!

Mike

3

Has anyone FAT Templates for Granulation or coating or tablet press for a Solid Oral Dosage Process

Much appreciated

Brian

4

Thank you Mike