Nathan Parker

Apr 12, 2024 | bioprocessonline.com | Nathan Parker |Claus Exenberger |Jean-Sebastien Steffen |Ian Burdick

The introduction of ICH Q14 to analytical procedure development provides guidance on the recommended approach to assay development and the justifications regulatory bodies require to demonstrate the development of a method. While applying an AQbD approach may require more upfront work, the advantages are a better understood and more robust method, with greater regulatory flexibility.

Jan 9, 2024 | bioprocessonline.com | Nathan Parker

By Nathan Parker, principal consultant, Parker Biopharmaceutical Consulting In November 2023, the FDA finalized the COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers Guidance for Industry.1 While the guidance is only intended to remain in effect until Aug. 7, 2024, it contains information organized in a way that will continue to be useful even if the guidance is not further revised and extended. Why Is FDA Just Finalizing COVID-related Guidance Now?