MTS HELPDESK:
ICH Q2(R2) directs that for the results of accuracy and precision, the confidence interval should be compared to the acceptance criteria. How are these confidence intervals calculated?
Tag: ICH
JPAG Symposium: Analytical Method Technology Transfers
The MTS consultant, Oona McPolin, will be presenting at the upcoming JPAG symposium at the RSC in London on the topic of analytical method transfer.
New dates in 2026 for the course, ‘What’s New in ICH Q2(R2) and Q14?’
We have added two new dates in 2026 for our course, ‘What’s New in ICH Q2(R2) and Q14?’ in September and November. On this course you will learn about the recent changes to the ICH guidance, Q2(R2), ‘Validation of Analytical Procedures’, and about the new guidance Q14, ‘Analytical Procedure Development’.
What is Analytical Method Validation?
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.
When do I Need to Follow ICH Q2(R2) & Q14?
MTS HELPDESK:
When do I have to start following the updated ICH guideline, Q2(R2) and the new guideline, Q14?
Why Perform a Validation Gap Assessment?
MTS HELPDESK:
Why would it be necessary to perform a gap assessment of validation data that has been generated following ICH guideline, Q2(R1) against the updated version, Q2(R2)?