Pharmaceutical Development: New Challenges through ICH Q8 Annex

In June 2009 the EMEA document EMEA/CHMP/ICH/518819/2007 will become effective. This means that the ICH Q8 Annex - Pharmaceutical Development - will also be valid in Europe.

This Annex demonstrates how the principles of Quality by Design (QbD) can be implemented for all dosage forms. It also introduces the new concepts as, for instance, Design Space.

From the authorisation perspective it is important that the gained knowledge submitted to the authorities is relevant for a scientific and risk-based regulatory evaluation - instead of the quantity of collected data.

According to the new Annex pharmaceutical development includes:

  • To define the "Quality Target Product Profile" (QTPP)
  • To identify the potential "Critical Quality Attributes" of the medicinal product
  • To determine the critical "Critical Quality Attributes" of the APIs and excipients
  • To select the appropriate manufacturing process
  • To determine the control strategy

In this context it is necessary to find out what material characteristics and process parameters are linked with the product CQA. And through a better product and process understanding it is possible to develop the appropriate control strategy, which, for instance, can also include proposals for a design space or a "real-time release".

In the future it is supposed to be the pharmaceutical developement's goal to systematically gain a better understanding for both the product and process in the development.

Here the Quality Target Product Profile (QTPP) builds the basis for the design of the product development. And the Critical Quality Attributes (CQA) are physical, chemical, biological, or microbiological properties or characteristics that should be within an appropriate limit, range, or distribution to ensure the desired product quality.

The relationship between process input (material characteristics and process parameters) and the critical quality attributes (CQA) can then be described in the design space. The Annex further describes what the construction of the Design Space can look like in detail.
 
The glossary defines individual terms like Design Space, Quality by Design, etc. The appendix 1 distinguishes in a table between a minimal and an intensified, QbD-oriented development approach.

With regard to the QbD approach the document refers to PAT tools and states that it is also possible to employ PAT tools including appropriate "feedforward" and "feedback" controls.

The complete EMEA document on "ICH Topic Q 8 Annex Pharmaceutical Development" can be found here.

QbD and PAT will also be in the center of attention at the University of Heidelberg QbD/PAT Conference 2009, scheduled in Heidelberg, Germany, from 29 September to 1 October. The conference programme with speakers from industry, leading universities (University of Heidelberg, Duquesne Univeristy, USA) and authorities (Dr. Jon Clark, FDA and David Cockburn, EMEA) is available at www.pat-conference.org.

Author:
Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

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