Executive Briefing Series (formerly The Food & Drug Letter)

During three workshop training sessions, the International Conference on Harmonisation (ICH) Quality Implementation Working Group (Q-IWG) heard dozens of questions about its Q8, Q9 and Q10 guidelines. As a result, the working group prepared a recently released “Points to Consider” document covering topics relevant to the implementation of the three quality guidelines. These are intended to supplement the existing guidance Q8 (R2), Q9, Q10 and Questions & Answers and workshop training materials already produced by this group. These points are intended to provide clarity to both industry and regulators and to facilitate the preparation, assessment, and inspection related to applications filed for marketing authorizations. This issue of The Food & Drug Letter excerpts those points to consider. ICH emphasizes that applicants’ development approach should be adapted based on the complexity and specificity of product and process. Using the Quality by Design (QbD) approach does not change regional regulatory requirements but can provide opportunities for more flexible approaches to meet them. In all cases, good manufacturing practice (GMP) compliance is expected.

Scientific rationale and quality risk management (QRM) processes are used to reach a conclusion on what are critical quality attributes (CQAs) and critical process parameters (CPPs) for a given product and process.

This document is intended to provide suggestions on the type of information and the level of documentation that is appropriate to support a proposal for enhanced QbD approach.

A design space can be updated over the lifecycle as additional knowledge is gained. Risk assessments, as part of the risk management process, help steer the focus of development studies and define the design space.