MTS HELPDESK:
What are the differences between the ICH guideline, Q2(R1) and the updated version, Q2(R2), that would be identified in a gap assessment of an analytical procedure validation study which was originally performed following version Q2(R1)?
Tag: Lifecycle
ICH Q2(R2)/Q14 IWG Training Materials
Training materials created by the Q2(R2)/Q14 ICH Working Group, relating to ICH Q2(R2) “Validation of Analytical Procedures” and ICH Q14 “Analytical Procedure Development”, are now available on the ICH Website. There are 7 training modules provided as pdf documents which aim to facilititate interpretation and implementation of the guidelines. The training materials are available for […]
What is an Analytical Procedure Lifecycle?
MTS HELPDESK:
What are the elements of the Analytical Procedure Lifecycle, as mentioned in guidance documents such as ICH Q14 and USP <1220>?
New Course: What’s New in ICH Q2(R2) and Q14?
We are pleased to announce that we have a new short course on the topic of the ICH guidance documents, Q2(R2) and Q14, that is aimed at both our previous learners who have completed our validation course, and also at anyone who is experienced in validation and wants to know more. The course is currently […]
Updated ICH Q2(R2) and New Q14 Guidelines Finalised
The Assembly of the ICH met in-person in Prague on 31 October & 1 November 2023. The revised guideline on “Validation of Analytical Procedures”, ICH Q2(R2), and the new guideline on “Analytical Procedure Development”, ICH Q14, reached Step 4 and were adopted by the ICH Assembly Regulatory Members. The final versions of both guidelines are […]
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 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: […]