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)?
Category: Resource Library
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>?
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, […]
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 […]
Limit of Quantitation: Does it Matter?
MTS HELPDESK: Is the limit of quanitation always important when validating methods for impurities?