A new general chapter on Comparability of alternative analytical procedures (5.27) has been published in Supplement 11.5 of the European Pharmacopoeia (Ph. Eur.) in January 2024. While this text does not introduce any new requirements, it does provide valuable information on how users wishing to employ an alternative analytical procedure can demonstrate its comparability to the pharmacopoeial procedure (Ph. Eur. General Notices section 1.1.2.5: “… 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.”).
The webinar describes the comparability process clearly, breaking it down into individual steps and listing the prerequisites for the comparability study. Finally, key take-away points are emphasised.
Target audience
This webinar is of interest to professionals working in quality control/compliance, manufacturing and regulatory affairs, as well as in national regulatory agencies and inspection authorities.
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