The European Medicines Agency has updated the ICH Q2(R2) Guideline on validation of analytical procedures. This update was published in December 2023, and the guideline will be effective from June 14th, 2024.
This marks a pivotal moment in regulatory guidance for pharmaceutical professionals, with its final adoption signaling a step forward in the analytical procedure validation landscape.
Complete revision of the Guidelines includes: Newer technologies serve as a collection of terms and their definitions. Designed to bridge the differences that exist among the various compendia and documents of ICH member regulatory authorities, the guideline also incorporates principles described in ICH Q8-Q10, which did not exist in previous Q2(R1).
In addition, The Guideline provides an inter-relationship with ICH Q14 as knowledge generated during analytical procedure development as described in ICH Q14 aids the design of a validation study.
You can read the complete updated guideline here: ICH Q2 (R2)
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