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Industry Prepares For Emerging ICH Q14 Quality-By-Design Approach To Analytical Methods

 
• By Joanne S. Eglovitch

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.  

Portable Raman Spectrometer - Image

More than a decade after the pharmaceutical industry and leading regulatory authorities adopted the quality-by-design approach to pharmaceutical development, it looks like QbD concepts are finally going to extend to analytical methods. ICH is planning to propose guidance in early 2020 that it hopes to finalize a year later. Meanwhile, a European industry group has provided additional guidance to help industry prepare for the emerging lifecycle management approach to analytical procedures.

A paper from the European Federation of Pharmaceutical Industries and Associations explains how manufacturers can implement some of the enhanced approaches to analytical method validation in anticipation of the International...

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