MTS Helpdesk Question: What are the elements of the Analytical Procedure Lifecycle, as mentioned in guidance documents such as ICH Q14 and USP <1220>? Answer: An analytical procedure (or method) lifecycle consists of the activities associated with the procedure development, validation, routine use, transfer to another laboratory, and change control, throughout the period of time […]
Tag: ICH
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 […]
ICH Q2(R2) & Q14 Now Available
The final versions of ICH Q2(R2) Validation of Analytical Procedures, and Q14 Analytical Procedure Development, are now available on the ICH website. You can view the pdfs using the buttons below. Related content from our Resources Library Services related to this content that we offer MTS offers a new short course relating to these updates, […]
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 […]
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 […]
Limit of Quantitation: Does it Matter?
MTS Helpdesk Question: Is the limit of quanitation always important when validating methods for impurities? Answer: Defined as “the lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy” in ICH Q2, limit of quantitation (or ‘quantitation limit’ in the ICH terminology) is an important method performance characteristic […]