Tuesday 7 June 2022

New general text on comparability of alternative analytical procedures


The European Pharmacopoeia (Ph. Eur.) is seeking feedback on its new general text on the comparability of alternative analytical procedures (5.27). The draft text elaborates on the requirement expressed more succinctly in the Ph. Eur. General Notices, according to which a user may – with the agreement of the competent authority – use alternative analytical procedures for control purposes provided that they enable an unequivocal decision to be made with regard to compliance with the standards of the monographs if the official procedures were used.


The 64-page ICH Q14 document proposes to harmonize the scientific approaches for analytical procedures development by describing a minimal or an enhanced approach. It also describes the elements on an analytical target profile (ATP) which is incorporated in the enhanced approach.




The new general text is published in Pharmeuropa 34.2 for public consultation during Q2 2022. See: https://pharmeuropa.edqm.eu/home


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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