Draft Annex to ICH Q8 Clarifies Key Concepts

Rockville, MD (Jan. 10)-The US Food and Drug Administration published a draft annex to its ICH Q8 Pharmaceutical Development guidance that clarifies the document’s key concepts. The draft guidance is titled ICH Q8 (R1) Pharmaceutical Development Revision 1.

The new annex describes the principles of quality by design (QbD) and explains how manufacturers can implement concepts listed in ICH Q8 (e.g., design space) for all dosage forms. The guidance states that applying QbD and quality risk management creates opportunities “to enhance science- and risk-based regulatory approaches.”

In the draft document, FDA encourages manufacturers to adopt a systematic method for understanding their products and manufacturing processes. Such a strategy “can create a basis for more flexible regulatory approaches,” according the annex.

One major section of the annex examines the elements that should be included in pharmaceutical development. The section suggests systematic ways for manufacturers to gain a thorough understanding of the products and processes they develop. It lists the purposes and advantages of tools such as target product profiles, critical quality attributes, risk assessment, design space, control strategy, and life cycle management.

A subsequent section of the annex offers advice about submitting pharmaceutical development information in a common technical document format. The annex states that data derived from tools that are part of the applicant’s pharmaceutical quality system (e.g., product life cycle management and continual improvement) do not need to be submitted in a registration application. The draft guidance says “the degree of regulatory flexibility is predicated on the level of relevant scientific knowledge provided in the registration application.”

For the full text of the draft guidance, click here.