Where can i find documents on FAT & SAT tests for introducing new equipment in the pharmaceutical industry?
You may want to contact one of Wyeth Carolina’s FAT Team Members. “Teaming up for FAT and SAT Wyeth’s team worked closely with Wilco at every point in the project’s development life cycle, from the project scope and User Requirement Specifications (URS) stage up to the Qualification Process (Commissioning, IQ, OQ, PQ). For both parties, the goals were an implementation that would achieve consistent, reproducible readings, and that was 99.99% certain to reject any vials with air ingress. Factory Acceptance and Site Acceptance Tests (FAT, SAT) provided the grounds for the machine’s development phases and performance evaluation. The Factory Acceptance Test (FAT) was written with the development process in mind. No historical data were available for these particular inspection criteria. Set point development was a critical part of the FAT process. Normally, a FAT is conducted entirely against the function and design documents designed to meet the URS. In this case, though, since the produc
