Q7A says that you can use material prior to its release or prior to its completing testing, as long
as you have an appropriate system to allow its use under quarantine. It does not define what has
to be in that appropriate system. It would certainly seem that an appropriate system should be
procedurized, so you should have a written procedure that says what you are going to do.
Obviously, if you are going to have a written procedure, then it has to be approved by the quality
unit. The system will probably only permit use of material for which you have good data; material
for which you do not suspect that there is any problem. You are just waiting to complete the
testing, or validation studies, or something like that. A critical part of the system is that you really
do have a good system to “flag” the material in which this unreleased material is used. So if there
is a problem, you know exactly where it was used. You also then have a system to make sure
that, prior to release of the material in which this unreleased material has been used, there is a
way to verify that the unreleased incoming raw material or the API really was released before the
final product goes out. Those would certainly seem like some of the key things that would have to
be in an appropriate system, but Q7A does not specify what those characteristics have to be.
