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…
