At its 152nd sessionthe European Pharmacopoeia Commission approved thepublication of a new edition of the Technical Guide for the elaboration ofmonographs. This guide is an essential tool for the drafting of monographsbut also for the transposition of analytical techniques and parameters into apharmacopoeial method. It helps to ensure a high level of harmonizationthroughout the texts of the Ph. Eur., written by the experts of the differentgroups.

PURPOSE OF THE GUIDE :

This document is a guide for the authorsof monographs and also a means of communicating the principles for the elaborationof monographs to the users of the European Pharmacopoeia (Ph. Eur.), especiallyindustry, licensing authorities and official medicines control laboratories.Since the principles applied and guidance given for the elaboration of monographsshould be the same as those applied by licensing authorities, the TechnicalGuide may also serve as a guideline in the elaboration of specificationsintended for inclusion in licensing applications.

It is necessary tounderstand that a monograph will be a mandatory standard and must be applicablein licensing procedures in all Member States of the Convention on theElaboration of a European Pharmacopoeia.

7th Edition of the Technical Guide

Source: EDQM