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By Kenneth Norris

Ken NorrisFor the past several years, AAPS and its Analysis and Pharmaceutical Quality (APQ) section have been discussing quality by design (QbD). A QbD approach to drug development requires that quality be designed into the product. As in the development of products and production processes, a QbD framework can also be applied to analytical methods. The APQ section started this discussion back in 2008 at an open forum titled Application of Principles of QbD to Analytical Methodologies, Specification and Control Strategies. This was followed up with a symposium at the 2011 annual meeting titled QbD Approach for Analytical Methods. Another session was given at the 2013 PITTCON Conference and Expo, cosponsored by the AAPS APQ section and the American Chemical Society’s Division of Analytical Chemistry, titled Understanding Analytical Method Variance and the Impact for QbD Filing for Pharmaceutical Products. So the question is, “Where are we now for analytical methods and a QbD approach?”

In the early 2000s, pharmaceutical companies (particularly manufacturing departments) were increasingly using Lean Six Sigma methodology/tools to reduce their operational costs and improve their products for patients. This led companies like GlaxoSmithKline (GSK) to scrutinize what they were doing to validate and transfer analytical methods. In 2005 GSK decided that their method validation and transfer efforts should ensure that its analytical methods are robust and rugged and provide reliable data throughout their life cycle of use; this was not assured by the existing activities. GSK quickly recognized that the same QbD principles that were being developed for manufacturing processes at the time (e.g., FDA’s current good manufacturing practice regulations for the Twenty-first Century, the International Conference on Harmonisation [ICH] Q8, ICHQ9) were equally applicable to analytical methods.

GSK subsequently established a cross-company team (involving scientists from development, manufacturing, and statistical sciences) to explore how the concepts of QbD could be applied to analytical methods. This led to writing internal guidance that detailed the QbD components and tools that could be applied to analytical methods, which was then shared across the industry in 2006–2007. GSK broke down QbD into four components, which were all underpinned by a knowledge management repository:

  • Method performance characteristics (including criteria),
  • Method development,
  • Risk assessment and analytical method design space definition, and
  • Analytical method control strategy.

In the September issue of the AAPS Newsmagazine, we review the history of the life-cycle approach/analytical QbD and how organizations such as the European Federation of Pharmaceutical Industries and Associations, U.S. Pharmacopeial Convention, and the Food and Drug Administration have approached this topic. Read Enhanced Approaches for Development and Utilization of Analytical Procedures, from the APQ section and then participate in the discussion point below. This cover article was co-authored by Kimber Barnett, Phil Borman, and Oliver Grosche.

Where are we now for analytical methods and a QbD approach? What changes do you see in the evolution of the life-cycle management for analytical methods?

Kenneth Norris is a Principal Scientist at Pfizer Inc. He currently serves as the chair for the AAPS Analysis and Pharmaceutical Quality section.