In the past there has always been a difference between the qualified person as defined in Europe and his or her responsibility and the responsibilities deriving from the education of a person are being seen in the U.S. Can you comment whether this continues to exist and is being seen differently? Basically we’re looking at the European question of a qualified person versus here

Q7A does not address the issue of qualified person. Section 3.1 reads, “There should be an
adequate number of personnel qualified by appropriate education, training, and/or experience to
perform and supervise the manufacture of intermediates and APIs.” In the European Union there
is a requirement that the final release of medicinal products (finished pharmaceuticals) be done
by a Qualified Person. This Qualified Person is typically a pharmacist. The EU does not require a
Qualified Person to release APIs.
In Japan there is a requirement that a security pharmacist has to release all the APIs.
Q7A can be overridden by regional requirements, but the qualified person was intentionally
excluded in Q7A. It is important that person have the appropriate education and experience for
the processes and products that are being reviewed and released. In some cases it makes more
sense to have a chemistry or biochemistry degree than a pharmacy degree.