MTS Helpdesk
Question:
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)?
Answer:
In a previous issue of the MTS Helpdesk, the question related to what differences would be identified in a gap assessment of an analytical procedure validation study which was originally performed following version Q2(R1). The question in this issue quite rightly asks: why would you need to do this assessment?
There are two situations when an assessment of validation data against the current ICH guideline, Q2(R2) would be performed. These are:
- The method is about to be transferred to another laboratory, and
- Analytical procedure lifecycle management is being performed.
1. Analytical Method Transfer
In the case of a transfer being performed under the GMP guidelines from EMA, the following section in Eudralex, volume 4, chapter 6 would apply:
“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 makes it very clear 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 and the necessary validation is performed. This would also apply in case of a method validation that predates ICH Q2 entirely.
2. Analytical Procedure Lifecycle Management
The lifecycle management of analytical procedures is considered best practice in pharmaceutical and biopharmaceutical analytical laboratories and 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.
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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.