Author: MTS

Examples of Risk Assessment for Method Verification

EDQM has published a companion text to the general chapter 5.26, Implementation of pharmacopoeial procedures, which provides examples of risk assessments for the implementation process, applied to a variety of different types of analytical methods. The risk assessments are an excellent resource, not just for method verification but also for other lifecycle management activities, such […]

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 […]

JPAG Symposium: Stability VI

The MTS consultant, Oona McPolin, will deliver a presentation entitled, ‘Challenges in Development and Validation of Stability Indicating Methodology‘ at the JPAG symposium, ‘Stability VI’ on the 30th June 2022, which will be held at the Royal Society of Chemistry in Burlington House, London. If you are interested in the analytical methodology used for supporting […]

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 […]

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: […]