Are complaint records required between different sites/operations of a single company, i.e. a drug product manufacturer at Site A and the API supplier at Site B? And, I will take this one step further. The API supplier actually might have two facilities that feed that drug product situation, because a lot of us have that situation in our plants. So, basically, the question becomes, where should the complaint records be kept and what are required.

It doesn’t matter. We don’t mandate that in Q7A. You should communicate with all the affected
sites and all the affected facilities. The requirement is that you make the communication, get
closure according to what’s required. But, it really makes no difference if it’s plant A of the
manufacturing company or plant B of the manufacturing company. If your procedure is in writing
and you show that you’ve gotten a close on the loop.
Those records should be readily available at the point of inspection or visit by the regulatory body,
or can be retrieved to demonstrate the closure.