Section 18 covers both classical fermentation and biotech. So Section 18 was designed to
provide principles that applied to both. Where possible we tried to highlight the differences
between classical and biotech, and in general, the controls needed for biotech are higher than
classical fermentation. However, there isn’t another GMP guidance that addresses classical
fermentation or biotech at least to the extent that Q7A does. Does it cover all possible aspects?
No. But it is an attempt to highlight the important aspects for these processes, and we were able
to reach agreement between the three ICH regions, which is also another really important point.
We do have that regulation in the U.S., but Q7A is applicable to all three of the ICH regions. Also
bear in mind that the filing requirements for biotech in classical fermentation are somewhat
different. The information submitted for the biotech processes exceeds what is submitted for
classical fermentation. This will be addressed further in the CTD, which is the common technical
document, which will also probably have higher expectations for biotech.
