MTS HELPDESK:
What is the difference between ‘validating’ and ‘qualifying’ an analytical method and what is the regulatory perspective on this issue?
Category: Validation
Confidence Intervals for Method Validation Data
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?
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)?
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)?