Direct Links to important GMP Excipient Guidelines

This document describes a uniform approach to the evaluation of changes in the manufacture and distribution of pharmaceutical excipients.

This guideline provides guidance on the documentation expected for sterile products in the quality dossier for a marketing authorisation application or a variation application for a medicinal product, (called quality dossier throughout the guideline), and the selection of appropriate methods of sterilisation for sterile products. Although, terminal sterilisation using a reference condition of the European Pharmacopoeia (Ph. Eur) is the method of choice whenever possible, this guideline provides information on when other terminal sterilisation processes, sterilising filtration or aseptic processing, (either alone or when combined with an additional terminal microbial reduction process), could be accepted as an alternative to a reference terminal sterilisation process.