Technical Guide - EDQM

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Technical Guidefor the elaboration of monographs European PharmacopoeiaEuropean Directorate for the Quality of Medicines & HealthCare 6th Edition - 2011 Council of Europe, 67075 Strasbourg Cedex, France - 2011All rights reservedMaking copies of this fi le for commercial purposes or posting this fi le on a web site that is open to public consultation is strictly Technical Guide FOR THE ELABORATION OF MONOGRAPHS 6th Edition 2011 CONTENTS 1. INTRODUCTION ........................................ ........................................ ........................................ ................... 6 PURPOSE OF THE Guide ........................................ ........................................ ........................................ . 6 TEST PROCEDURES.

may also serve as a guideline in the elaboration of specifications intended for inclusion in licensing applications. It is necessary to bear in mind that a monograph will be a mandatory standard and must be applicable in licensing procedures in all Member States of the Convention on the Elaboration of a European Pharmacopoeia.

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