There is no substitute for doing your “homework”, and the regulatory community can’t help you,
they can only assure you that you’ve done it properly. This begins in early development, or one
has to combine process development with product characterization, and begin to understand your
product and your process and know what belongs there. Get a handle on what it’s supposed to
look like and if you have a decent level of experience and analytical capability, it gives you the
maximum ability to generate an appropriate profile from which you can then monitor. It is
necessary to do your homework during development, so that when you file a license application
or a product approval application, you have the basis to, in fact, be able to do this. Staying current
with the analytical state-of-the-art is also very important in order to maximally assure that you can
do this to the extent that science will permit.
