MTS HELPDESK:
In ICH Q2(R2), the guideline about validation of analytical procedures that is used in the pharmaceutical/biopharma industry, it states that: ‘The objective of validation of an analytical procedure is to demonstrate that the analytical procedure is suitable for the intended purpose.’ Therefore, the aim of a validation study is to generate evidence which provides the proof that the method works as intended.
Tag: ICH
ICH Q2(R2) Validation Gap Assessment
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)?
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 […]
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, […]