In the ICH Steering Committee meeting in November 2007 the Annex to ICH Guideline Q8 has reached step 3 in the ICH process. It was presented to the regulatory parties for consultation. The European Medicines Agency (EMEA) has now also published the Annex according to the ICH bylaws (CPMP/ICH/518819/07). The FDA and the Japanese authority will follow soon. The deadline for comments is May 2008.

The Annex provides further clarification of key concepts outlined in the ICH Q8 guideline. In addition, this annex describes the principles of quality by design (QbD). It shows how concepts and tools (e.g., design space) outlined in the parent Q8 document could be put into practice by the applicant for all dosage forms.

Other topics are for example Critical Quality Attributes (CQAs). Drug product CQAs are used to guide the product and process development. Potential drug product CQAs can be identified from the target product profile and/or prior knowledge. Risk assessment is a valuable science-based process used in quality risk management (see ICH Q9) that can aid in identifying which material attributes and process parameters have an effect on product CQAs. While the risk assessment is typically performed early in the pharmaceutical development, it can be helpful to repeat the risk assessment as information and gaining greater knowledge. The linkage between the process inputs (input variables and process parameters) and the critical quality attributes can then be described in the design space.

A table is also part of this document to illustrate some potential contrasts between what might be considered a minimal approach and an enhanced approach regarding different aspects of pharmaceutical development and lifecycle management.

The documents are available in the Internet at the following addresses:
http://www.ich.org/LOB/media/MEDIA4349.pdf and http://www.emea.europa.eu/pdfs/human/ich/51881907en.pdf