If it’s a product contact surface, it’s certainly more critical. Whether it needs to be validated is
going to depend upon whether this is storing a critical material. Is it a finished API; is it an
Intermediate, or what? Certainly, you need to have data that shows what you’ve chosen to be in
contact with is acceptable. Your company may need specific information to tell you whether or not
it should to be validated. If it’s not critical, it probably doesn’t need validation, but it certainly
should have data to show that it’s suitable.
Monitoring can be done on a continuous basis or manually – either one. We don’t mandate which
way you need to do it. You need to do some kind of monitoring for the quality. If you could do that
automated, online, and record that, so be it. There’s nothing that says you can’t do it that way.
We’d like to go back to this question about reuse of containers. Common sense usually applies in
many of these situations. You do whatever you think is necessary in order to accomplish the task
at hand.
There are certain things that are intuitively obvious that you really should validate, and there are
things that are common sense driven that tell you, you do your testing, and you make sure it
works. Put your dollars and your emphasis on the things that are really meaningful.
Monitoring and storage of solvents stored in bulk should be described in procedures established
by the firm. If Q7A requires certain things, they need to be followed. If no requirements are
described, there is no need to perform extra work.
