Article | May 13, 2022

New ICH Q14 Guidance Applies QbD To Analytical Procedures

By Brian Glass, senior analytical consultant, Pharmatech Associates

Chromatography GettyImages-1392302602

ICH's new draft guidance (Q14) for Analytical Procedure Development describes an enhanced approach for method development, validation, and life cycle management.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.

access the Article!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Bioprocess Online? Subscribe today.

Subscribe to Bioprocess Online X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Bioprocess Online

Pharmatech Associates - A USP Company