Regarding the table indicating application of Q7A to biotech processes (Section 1.3 Scope, page 4), and the arrow indicating increasing GMP, does this indicate a change in CBER’s attitude toward GMP levels from early process steps to late process steps, or is the attitude still in place that GMP levels should be consistent through the entire process?

It hasn’t really changed the CBER perspective. We have been applying the GMPs from start to
finish of a process. Not only is it necessary to control the process, but also CBER regulations
make a direct link to the Code of Federal Regulations Part 211. Moreover, since we license bulk
facilities, we felt it necessary to have these levels of control. In a general sense, as you move
through the process, requirements get tighter, and that is consistent with the arrow in saying
increasing GMP requirements. However, we would expect to see these controls in place from
start to finish. There are certain early steps that are not really covered here (in ICH Q7A) but
would normally be part of an application (for product authorization), where we would certainly
expect the GMPs to be applied. These issues were just a little bit beyond the scope of this
document, because we didn’t really want to get into the source cell issues. This may be dealt with
in another ICH guidance document to come later.