FDA adapts ICH Q8 (R2) Pharmaceutical Development as Guidance for Industry

The FDA has now also published the ICH Q8 document and its annex as Q8(R2) Pharmaceutical Development Guidance for Industry.

The annex to the respective guidance elaborates on the central concepts pointed out in the ICH Q8 Guideline. It describes the principles of "Quality by Design" (QbD) more comprehensively. It describes how applicants can put concepts and tools (like e.g. Design Space) into practice for various forms.

The document also deals with the "Critical Quality Attributes" (CQAs). These CQAs of medicinal products are used to control the product and process development. Potential CQAs can be deduced from the profile of the target product and from the already gathered pieces of information. In this context, risk analysis is a valuable scientifically-based process that is implemented within the framework of Quality Risk Management (see also ICH Q9) and can help to identify the material properties and process parameters that have an influence on the CQAs. While risk analysis is typically conducted in an early phase of product development, it can be helpful to repeat the risk analysis in order to gain information and more profound knowledge. The connection between process inputs (input of the variables and process parameters) and the CQAs can then be described in the Design Space.

Appendix 1 of the document includes a well-structured table that highlights some potential differences between a minimum approach and an extended Quality-by-Design approach to pharmaceutical development and to lifecycle management.

Appendix 2 contains a number of very clear illustrations and examples for clarification.

The document can be found here.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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