Q7A states in 8.12: “critical weighing, measuring or subdividing operation should be witnessed or
subjected to an equivalent control”. Q7A goes on in 8.13 “Other critical activities should be
witness or subjected to an equivalent control.” This is one of those areas where Q7A is trying to
address the uniqueness of API manufacturing recognizing that many times API processes are
handled or controlled by a common control panel. Operators may be sitting in a control room
pushing buttons to add reagents or solvents to reactors or tanks. Imagine how cumbersome it
would be if the operator had to run down to the tank and make sure that the acid was actually
added to the tank. That is not an expectation in API manufacturing. That’s why Q7A allows an
equivalent control. The equivalent control may be a printout from an instrument showing the
amount of e.g. reagent added. In API manufacturing a lot of the processes are in closed systems,
many times it’s difficult to actually have a second person verify a particular operation and sign off
on the batch record. That’s why Q7A allows equivalent means of doing this.
