A new general chapter, Implementation of pharmacopoeial procedures (5.26), has just been published in the 11th Edition of the European Pharmacopoeia (Ph. Eur.). The text was adopted by the Ph. Eur. Commission at its session in November 2021.
This new general text elaborates on the requirement expressed more succinctly in the Ph. Eur. General Notices, according to which “when implementing a Ph. Eur. analytical procedure, the user must assess whether and to what extent its suitability under the actual conditions of use needs to be demonstrated according to relevant monographs, general chapters and quality systems.”
Published for information, Implementation of pharmacopoeial procedures (5.26) describes a possible approach to the implementation of analytical procedures, while recognising that others may also be appropriate. It represents a major addition to the Ph. Eur. as it provides more detailed information on one of the key processes underpinning the correct usage of Ph. Eur. monographs.
The Working Party responsible for elaborating the new chapter also recently sought and obtained the approval of the Ph. Eur. Commission (173rd session in June 2022) to publish a companion text comprising examples of implementation processes applied to various analytical procedures. This example document will be accessible via the Knowledge database entry for general text 5.26 (under Additional Information) and can be used more widely as a means of better understanding the concepts laid out in the new general text.
The working party and the European Directorate for the Quality of Medicines & HealthCare (EDQM) hope that general text 5.26 and the example document will prove valuable both to users who are setting up an approach for the implementation of pharmacopoeial procedures and during evaluation.