Will the Quality by Design Approach Increase Costs and Resources?

GMP News
25 June 2008

Will the Quality by Design Approach Increase Costs and Resources?

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:

Pharmaceutical Quality - A New Vision.

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

Inter-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. "

Source: www.ich.org

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