ICH Proposals Would Streamline Analytical Technology Adoption
ICH regulatory members will seek input on guidelines that bring quality-by-design concepts to the development and evolution of the analytical methods required for release of drug products.
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The ICH is expected to release for public comment early next year its draft Q14 guideline establishing a lifecycle approach for analytical testing, as well as a Q2(R2) guideline to add some newer analytical methods.
EU industry group advises drug makers on how to prepare for enhanced quality-by-design approaches to analytical methods that the International Conference on Harmonization plans to propose early next year. ICH recently shared its concept, which involves revising its Q2(R2) guideline and adding a Q14 guideline, and its business plan for establishing the guidance.
Agency’s revised OOS guidance clarifies positions on outlier test results, averaging of HPLC results and some finer points around OOS questions. These could marginally improve compliance but won’t impact industry with nearly the force of the original 2006 guidance or the 1993 court ruling that preceded it.