During the ICH Tokyo Symposium, the new ICH approach to pharmaceutical Quality
Assurance, consisting of ICH Q8, Q9 and Q10, was discussed. Dr Jean-Louis
Robert, EU Rapporteur at the ICH, explained the concept as well as its influence
on the necessary resources and the resulting costs. In the following we are
quoting from his presentation (as published on the ICH Webpage).
"The International Conference on Harmonisation (ICH) of Technical
Requirements for Registration of Pharmaceuticals for Human Use was born in April
1990 at a meeting in Brussels. Since then, a lot of progress has been made.
In Brussels 2003, after a long discussion, the following vision on quality has
been agreed on:
This new vision or paradigm considers the medicinal product during its
lifecycle, i.e. starting from development through technical transfer to routine
manufacturing, emphasises on a better product and process understanding and on
deriving specifications from this understanding. The whole should be achieved by
having a more systematic approach to development, by using risk management tools
and by working within a Q10 type quality system.
Q8 has defined several concepts like PAT, design space, real time release,
control strategies, systematic approach to development. If Q8 addresses the drug
product, experts agree, that the same principles and concepts described there,
are also applicable to the drug substance, both chemically and biotech derived.
It is rather the complexity of the product than the type of product itself which
will impact implementation.
Relationship between Q8, Q9 and Q10
Questions and Answers
Tominaga: So, probably as a starter, looking at your diagrams on the process,
the quality by design approach and quality space approach, it is complicated and
almost daunting, in my opinion. So my question is, does the quality by design
approach automatically increase the regulatory requirements and hence the
resources imposed upon the applicant? What do you think about those aspects?
Robert: The question is a little tricky. Personally, I do not think that this
will trigger new requirements or that an enhanced level of resources will be
required. It always depends on how you look at it. Pharmaceutical development
has to be done anyhow, so before a company releases a product onto the market it
has to perform pharmaceutical development studies in order to make sure that the
product will be of consistent good quality and be meeting performance
requirements. If we understand, by "quality by design", a more systematic
approach to development, I am sure that this will help the applicant or the
manufacturer, to reach faster the same degree of knowledge. Of course, if one
wants to do what we refer to as "achieving enhanced knowledge", then you will be
able, for instance, to establish a design space or to perform real time release.
So, if a manufacturer wants to go in this direction, to take advantage of these
opportunities, this will require more investment. Short-term you might have to
do more investment, but long-term I would say you will also have some benefit
from it. To my opinion, I think, that also for the basic or the traditional
development approach, a systematic way will lower your cost. If you want to
achieve "enhanced knowledge", it will require more resources, but long-term it
will also be of some benefit for the company. So if one makes the balance at the
end, it will probably not raise the cost or raise the resources compared to the
benefits which a manufacturer can get. "