ICH Updates in Our Validation Courses

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. We have modified our courses, ‘Validation, Verification & Transfer of Methods for Pharmaceutical Analysis,’ and, ‘Validation, Verification & Transfer of Methods for Biopharmaceutical Analysis‘, to ensure that attendees are completely ready for the introduction of the new version of the Q2 (R2) guideline and are familar with the new Q14 guideline and how it relates to method validation.

Although this guidance is still in a draft status, and thus may not be the same in the finalised document, many of the new features are good advice even if they don’t end up in the final version.

Related content from our Resources Library
JPAG Symposium: Stability VI
The MTS consultant, Oona McPolin, will deliver a presentation entitled, 'Challenges in Development and Validation of Stability Indicating Methodology' at …
Limit of Quantitation: Does it Matter?
Defined as "the  lowest amount of analyte  in a  sample which  can be quantitatively determined with  suitable precision and  accuracy" …
Drafts of ICH Q2(R2) and Q14 on Public Consultation
Draft versions of the revision of ICH Q2, Validation of Analytical Procedures, and also the new guideline Q14, Analytical Procedure …