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The ICH Plans To Propose Q14 Guideline On Analytical Testing In January

 
• By Joanne S. Eglovitch

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.

Portable Raman Spectrometer
ICH To Soon Modernize Analytical Testing Guidelines • Source: Shutterstock

The International Council on Harmonization is expected to propose for public consultation a guideline that establishes a lifecycle approach to analytical method validation in January 2021, said a member of the ICH expert working group that is developing the Q14 guideline.

The expert working group also plans to release another ICH guideline, Q2(R2), that establishes newer analytical procedures such as near-infrared (NIR) spectroscopy and Raman spectroscopy, and to issue this draft...

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