Published in: Contract Pharma (September 2022 issue)
Published on: September 13, 2022
When reviewing health agency citations, it is clear that a common area of focus by investigators during inspections is the stability program and the data that is generated by the program. Why is this? Obviously, there can be numerous reasons such as that stability studies are frequently on the critical path when seeking agency approval and the resource demands associated with stability testing and the competing priorities. But one of the issues, I believe, is that stability testing is commonly outsourced, which puts a focus on the vendor qualification/oversight program, along with the associated quality agreements, adding a complexity/risk that investigators are aware of.