Presentation: IQ Consortium Initiatives with Respect to AQbD/Analytical Method Lifecycle Management
Mark Argentine and Qinggang Wang presented “IQ Consortium Initiatives with Respect to AQbD/Analytical Method Lifecycle Management” as part of the morning workshop on “Recent Initiatives by FDA and Compendia: How do They Impact Analytical Development for Pharmaceuticals” at Pittcon on March 11, 2015. Workshop speakers included the following:
Shreekant Karmarkar (Baxter) – A Review of Applying QbD Concepts for Analytical Development for Pharmaceutical Products.
Mark Argentine (Eli Lilly and Company) – IQ Consortium Initiatives with Respect to AQbD/Analytical Method Lifecycle Management
Horatio Pappa (USP) – Lifecycle Management Concepts to Analytical Procedures: A Compendial Perspective
Bruno Boulanger (Arlenda) – Why the Tolerance Intervals Fill the Gap Between Method Validation and QbD Guidances: The USP Trend
Richard Versput (S-Matrix) – A Perfect Storm of Technologies Drives QbD-aligned LC Method Development
There have been a number of initiatives in the past couple of years by compendia and FDA significantly impacting analytical development practices at the pharmaceutical companies in support of new drug products. For example, USP has published stimuli articles on LifeCycle Management of Analytical Procedures in 2013 which is based upon process validations as described in ICH Q8, Q9, and Q10 and these concepts can be applied to analytical procedures. USP has then proposed a new chapter on requirements for compendial validations to replace the existing chapter. In a couple of other stimuli articles, USP has described new approaches on analytical method linearity and on alternatives to official compendial analytical procedures. FDA published draft guidance on analytical procedures and methods validation for drugs and biologics in 2014 describing the concepts of Design of Experiments. FDA and EMA have initiated a joint project on use of QbD concepts in analytical development for drug products. Renowned speakers will discuss impact of these initiatives on analytical development practices in the pharmaceutical industry.
IQ Presentation Abstract:
There has been a great deal of interest in Analytical Quality by Design (AQbD) and Analytical Method Lifecycle Management in the past few years, including the recent publication of the USP and FDA draft guidances on Analytical Lifecycle Management and Analytical Method Validation, respectively. Additionally, a collaborative group of pharmaceutical representatives was formed from the IQ Consortium to discuss these topics. One outcome of the discussions was the development of a risk-based strategy for assessing analytical method comparability and the management of analytical methods changes. In this presentation, we will highlight the risk-based strategy discussed surrounding analytical method comparability and will share additional discussion topics and activities by the IQ analytical working group surrounding AQbD and Analytical Method Lifecycle Management.