There were a number of issues with both how the products were regulated and source material
issues. There are differences in the regulations. Some of the testing requirements are different.
So, they were not included and they were specifically excluded from the scope of the document.
That is not to say that most of the principles in Q7A would not apply. Certainly record keeping,
validation issues, facility equipment, are general issues that would certainly apply to these
materials. However the specific manufacturing issues that relate to those products could not be
included in this document hence they were excluded.
