Tag: Lifecycle

Drafts of ICH Q2(R2) and Q14 on Public Consultation

Post author By MTS
Post date 28 March 2022
Categories In News, Validation

Draft versions of the revision of ICH Q2, Validation of Analytical Procedures, and also the new guideline Q14, Analytical Procedure Development, were published on the 24th March 2022. The deadline for comments is 31st July 2022. You can view the draft guidelines, and also a presentation from ICH about the guidelines, using the following links: […]

A Wish List for ICH Q2(R2), the Revision of the Guideline on Method Validation

Post author By MTS
Post date 29 October 2020
Categories In Articles, Resource Library, Validation

The ICH guideline on method validation, Q2 (R1) [1], is currently being updated and I thought it might be interesting to put together a wish list for the changes that I would like to see in the new version. Rather than a wide-ranging treatment of all analytical method validation related issues, such as how it […]