Friday 27 November 2020

Implementation of pharmacopoeial procedures


The European Pharmacopoeia (Ph.Eur.) is seeking feedback on its new general text on the implementation of pharmacopoeial procedures (this will become chapter 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.


For details, see:


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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