Technical Guide for the Elaboration of Monographs

I.1. PURPOSE OF THE GUIDE

This document is a guide for the authors of monographs and also a means of communicating the principles for the elaboration and revision of monographs to the users of the European Pharmacopoeia (Ph. Eur.), especially industry, licensing authorities and official medicines control laboratories. Since the principles applied and guidance given for the elaboration and revision of monographs should be the same as those applied by licensing authorities, this Technical guide may also serve as a guideline in the elaboration of specifications intended for inclusion in marketing authorisation applications.

It is necessary to bear in mind that a monograph will be a mandatory standard and must be applicable in marketing authorisation procedures in all states parties to the Convention on the Elaboration of a European Pharmacopoeia (hereinafter the “European Pharmacopoeia Convention”)

The term “elaboration” used hereinafter in this guide covers both “elaboration” and/or “revision”.

I.2. ANALYTICAL PROCEDURES 

The analytical procedures chosen for the identification tests, purity tests and assay(s) constituting the bulk of a pharmacopoeial monograph are preferably those already described and utilised in the Ph. Eur. In this context, the author of a monograph is referred not only to the General Chapters of the Ph. Eur. but also to published monographs on similar materials. The above considerations are intended to ensure a reasonable degree of harmonisation within the Ph. Eur. and only apply in cases where the procedures are found to be adequate for the specific purposes. However, due attention is also to be paid to the development of new procedures that offer significant improvements in terms of sensitivity, precision, accuracy or specificity/selectivity.

Analytical procedures included in monographs are validated as described in part III (ANALYTICAL VALIDATION) and other relevant specific parts of this guide. Validation reports are provided to the EDQM but are not published or otherwise provided to users.

The analytical procedures included in a monograph are validated and further verified in two or more laboratories. One of these may be the supplier of the procedure who initially validated it.

The instructions for any analytical procedure cover all factors that may influence the results and that are deemed essential for an experienced analyst working according to acknowledged laboratory practices to be able to perform the analysis without necessarily having any prior knowledge of the investigation in question. Variations in the description of similar analytical procedures are to be avoided

If it is expected that an analytical procedure will be used generally or if it requires a lengthy description and is used more than once, it may be proposed for inclusion in the general chapters of the Ph. Eur., to be referred to in the individual monographs. The procedures are prescribed on the scale conventionally applied in the Ph. Eur. except in cases where for reasons of availability of the material to be analysed, or because of its toxicity or its cost, work on a small scale would be advantageous.