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 […]
Category: Validation
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 […]
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:
Is the limit of quantitation always important when validating methods for impurities?
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: […]
How Much Forced Degradation in a Stress Study?
When I forcibly degrade my drug or drug product to create degradation products, how much degradation should I aim for?