What we’re trying to say here is that there are other sections of Q7A that may be applicable to
APIs produced by biotech and fermentation. That is, Section 18 provided specific information
related to the manufacture and control of these processes but that in reviewing Section 18 you
should not just focus on and read Section 18 and leave it at that. You probably need to look at
other sections of the document that could also have an impact on or be applicable to APIs
produced by biotech and fermentation. In other words, don’t look at Section 18 on its own and
ignore the rest of the document because there are other parts of Q7A that may apply to APIs
produced by biotech and fermentation processes.
Section 18 is very clear about this and states that it is not intended to stand by itself and that all
the other relevant sections of the Guideline apply.
