This gets into a fairly grey area and there are perhaps a couple of ways to approach it. One is to
attempt a “fingerprint” method that will give a profile that will point out some peaks that are
connected with the characteristics of the material that are required for the growth of the organism
in question. There are some kinds of media where immunological assays have been done to
assure the medium, in fact, contains, for example, bovine-derived casein as opposed to some
other kind of casein. So, depending upon what the issue might be, there might be different ways
of assessing identity, depending upon whether the concern is the correct origin, or correct
processing, or the use of the right kinds of (media) ingredients.
It is really an issue not so much for Q7A (GMPs) as it is for filing. This something you would work
out during your original filings. If, indeed, it is an issue connected with a new process, it will come
up during registration. If it’s defined there (in the regulatory submission), it is academic as far as
Q7A is concerned, because it will be predetermined what you need to do.
