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T101f - Analytical Procedure Validation and Development – Status Update

‐ May 12, 2020 1:25pm

The new ICH Q14 guideline is proposed to harmonise the scientific approaches to analytical procedure development and provide the principles relating to the dossier description. The new guideline will include elements of enhanced development for analytical procedures, which may contribute to more robust methods. This guideline is intended to improve regulatory communication between industry and regulators and facilitate more efficient, sound scientific and risk-based approval as well as post-approval change management of analytical procedures. The guidance will complement existing and in-draft ICH guidance. The revision of ICH Q2 will provide a general framework for validation of different analytical techniques for analysis of products in the scope of ICH Q6A and Q6B. This will include validation principles for spectroscopic or spectrometric techniques (NIR, Raman, NMR, MS etc.,) some of which often require multivariate statistical analyses. Validation principles for techniques for analysis of biological products are also covered. This presentation will give an update on progress with these two guidelines, explain the current structure and content and introduce some of the key concepts.


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