The European Pharmacopoeia (Ph. Eur.) is seeking feedback on its new general text on the implementation of pharmacopoeial procedures (5.26).
The draft text elaborates on the requirement expressed more succinctly in the Ph. Eur. General Notices, according to which “a user must assess whether and to what extent the suitability of the method [i.e. pharmacopoeial procedure] under the actual conditions of use needs to be demonstrated in compliance with relevant monographs, general chapters and quality systems”.
This new general text would represent a major addition to the Ph. Eur. as it provides more detailed information on one of the key processes underpinning correct use of Ph. Eur. monographs. The group of experts in charge of its elaboration and the EDQM hope that the draft text will prove valuable both to users who are setting up an approach for the implementation of pharmacopoeial procedures and during evaluation.
The new general text is published in Pharmeuropa 32.4 for public consultation from October until the end of December 2020. All interested parties are strongly encouraged to review the draft and submit their comments. For more information on how to comment, please consult our guide.
In view of the current situation faced by users in areas affected by COVID-19, the Ph. Eur. strongly recommends that those who wish to provide comments on a Pharmeuropa text, but are unable to do so before the end of the commenting period, contact their National Pharmacopoeia Authority (NPA) in Ph. Eur. member states or the EDQM (via its HelpDesk).