In the ICH Steering Committee meeting in November 2007 the Annex to ICHGuideline Q8 has reached step 3 in the ICH process. It was presented to theregulatory parties for consultation. The European Medicines Agency (EMEA) hasnow 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 commentsis May 2008.
The Annex provides further clarification of key concepts outlined in the ICH Q8guideline. In addition, this annex describes the principles of quality by design(QbD). It shows how concepts and tools (e.g., design space) outlined in theparent Q8 document could be put into practice by the applicant for all dosageforms.
Other topics are for example Critical Quality Attributes (CQAs). Drug productCQAs are used to guide the product and process development. Potential drugproduct CQAs can be identified from the target product profile and/or priorknowledge. Risk assessment is a valuable science-based process used in qualityrisk management (see ICH Q9) that can aid in identifying which materialattributes and process parameters have an effect on product CQAs. While the riskassessment is typically performed early in the pharmaceutical development, itcan be helpful to repeat the risk assessment as information and gaining greaterknowledge. The linkage between the process inputs (input variables and processparameters) and the critical quality attributes can then be described in thedesign space.
A table is also part of this document to illustrate some potential contrastsbetween what might be considered a minimal approach and an enhanced approachregarding different aspects of pharmaceutical development and lifecyclemanagement.
The documents are available in the Internet at the following addresses: