New general chapter on comparability of alternative analytical procedures published in European Pharmacopeia (from Catapult’s regulatory round-up – December 2023)

A new general chapter, Comparability of alternative analytical procedures (5.27), has been published in Supplement 11.5 of the European Pharmacopoeia (Ph. Eur.).

This new general chapter describes how to demonstrate the comparability of an alternative analytical procedure to a pharmacopeial analytical procedure, in line with the requirement laid down in section 1.1.2.3. of the Ph. Eur. General Notices.

General chapter 5.27. does not introduce any new requirements, but the text provides practical guidance on how users who wish to rely on an alternative analytical procedure instead of the pharmacopoeial procedure for their testing strategy can demonstrate comparability and indicates that this comparability must be maintained over the lifecycle of both analytical procedures.

The new general chapter, which may also be useful to assessors during their evaluation, emphasizes that other approaches to demonstrating comparability may also be appropriate.

Please find further information here.

Published on the 5th of january 2024. Read all of Catapult’s regulatory round-up here.