New ICH Q14 Guidance Applies QbD To Analytical Procedures

By Brian Glass, senior analytical consultant, Pharmatech Associates

ICH's new draft guidance (Q14) for Analytical Procedure Development describes an enhanced approach for method development, validation, and life cycle management. The enhanced approach described in Q14 employs elements of quality by design (QbD) and risk management tools and applies these to analytical procedures. While the enhanced approach is not mandatory, there are benefits to the methodology.

The primary advantage is gaining a deeper insight into critical method properties, providing more regulatory flexibility when changes are necessary. The enhanced approach allows the development and validation of an analytical control space that permits the adjustment of some variables (over a range of values) if necessary. Review the differences between this enhanced approach and the traditional approach and delve deeper into the potential benefits of this methodology.