MTS Helpdesk
Question:
Why would it be necessary to perform a gap assessment of validation data generated following the ICH Q2 (R1) guideline, against the updated R2 version?
Answer:
A previous MTS Helpdesk article focussed on what differences would be identified in a gap assessment of an analytical procedure validation study originally performed following version Q2(R1). But why would you need to do this assessment in the first place?
There are two situations when an assessment of validation data against the current guideline of ICH Q2(R2) would be performed. These are:
- The method is about to be transferred to another laboratory
- Analytical procedure lifecycle management is being performed.
1. Analytical Method Transfer
For a transfer performed under the GMP guidelines from EMA, the following applies:
“6.37 Prior to transferring a test method, the transferring site should verify that the test method(s) comply with those as described in the Marketing Authorisation or the relevant technical dossier. The original validation of the test method(s) should be reviewed to ensure compliance with current ICH/VICH requirements. A gap analysis should be performed and documented to identify any supplementary validation that should be performed, prior to commencing the technical transfer process.”
This is explicit that the validation of a method about to be transferred needs to be assessed against the current ICH guideline, and that any gaps are documented with the necessary validation performed. This would also apply for a method validation predating ICH Q2 entirely.
2. Analytical Procedure Lifecycle Management
The lifecycle management of analytical procedures is considered best practice in pharmaceutical and biopharmaceutical analytical laboratories. It is likely activities related to lifecycle management could include a gap assessment of method validation data against current standards, particularly for legacy products. ICH Q14 provides a useful framework and recommendations about this topic.
References
Eudralex, Vol 4, chapter 6, EMA
ICH Q2(R2) Validation of Analytical Procedures
ICH Q14 Analytical Procedure Development
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Related content from our Resources Library
MTS offers a short course, ‘What’s New in ICH Q2(R2) and Q14?‘, which fully explores the updates to Q2 in terms of the additional information that has been introduced, and the expected benefits, the potential additional validation requirements and associated gap assessment, when compared to previous requirements, and also to provide an overview of the contents of Q14 and how this new guideline relates to Q2(R2).
A full discussion of analytical procedure lifecycle management is included in our courses, ‘Validation, Verification and Transfer of Methods for Pharmaceutical Analysis‘, and ‘Validation, Verification and Transfer of Methods for Biopharmaceutical Analysis‘.
Visit our courses page for a full list of available courses and the schedule of currently available course dates.