The Principles Document outlines high-level principles for building quality into trials and is intended as a tool for inquiry into “critical to quality” factors (CTQs) and associated risks. The Principles Document asks questions to promote proactive, cross-functional discussions and critical thinking at the time of trial development about what is critical to quality for a specific trial, and about the events that might impede or facilitate achieving quality. It is not intended to be all-inclusive, serve as a checklist to be completed in isolation, or be a substitute for experience and critical thinking. Watch Ann Meeker-O'Connell from Johnson & Johnson provide an introduction to the QbD Principles Document.

PRINCIPLES DOCUMENT

The Principles Document (full text) is a reference tool for inquiry into “critical to quality” factors (CTQs). Note that this is NOT intended to be used as a checklist.

EXPLORING THE

CTQS
CTQs can be grouped into categories of feasibility, protocol design, patient safety, study conduct, study reporting and third-party service providers. We encourage you to use our Interactive tool to explore CTQs from the Principles Document.

PRESENTATION ON THE PRINCIPLES DOCUMENT

Presentation that reviews the Principles Document and how it can be used to facilitate ad