1. INTRODUCTION

This document describes a process for the evaluation and recommendation by the Q4B Expert Working Group ( EWG of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions .Following favourable evaluations , ICH will issue topic specific annexes with information about these texts and thei implementation ( the Q4B Outcomes ) .The Q4B evaluation process will prompt a Q4B EWG review to assess both the merit of the change and the appropriateness o any subsequent Q4B activity related to that text .