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.
Author: MTS
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)?
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