There are several major differences between the two documents. FDA’s March ’98 draft guidance
covered chemical synthesis manufacturing processes and the later isolation and purification steps
of APIs produced by biotech and fermentation processes. The scope of Q7A is broader.
In addition, Q7A has a chapter on agents, brokers, distributors, and all those other organizations.
There’s also a chapter in Q7A related to biotech and fermentation. Q7A only covers APIs
intended for human drug products not veterinary drug applications. There were other issues, such
as validation issues, that were either removed or clarified. There were purchasing requirements.
There were a number of issues that, quite frankly, made the Q7 negotiation worthwhile for both
the regulators and industry.