A new general chapter, Comparability of alternative analytical procedures (5.27), has been published in Supplement 11.5 of the European Pharmacopoeia (Ph. Eur.). The text was adopted by the European Pharmacopoeia Commission at its 176th session in June 2023.
This new general chapter describes how to demonstrate the comparability of an alternative analytical procedure to a pharmacopoeial analytical procedure, in line with the requirement laid down in section 1.1.2.5 of the Ph. Eur. General Notices, which states: “… alternative analytical procedures may be used for control purposes, provided that they enable an unequivocal decision to be made as to whether compliance with the standards of the monographs would be achieved if the official procedures were used.”
General chapter 5.27. Comparability of alternative analytical procedures, does not introduce any new requirements, but is published for information. 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, emphasises that other approaches to demonstrating comparability may also be appropriate.
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