Direct Links to important GMP Excipient Guidelines

Eudralex Volume 3 Questions and answers on wheat starch containing gluten in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/00 Rev.1)

more

Eudralex Volume 3 Concept paper on the need for revision of the guideline on excipients in the label and package leaflet of medicinal products for human use (CPMP/463/00)

more

Eudralex Volume 3 Questions and Answers on Benzakonium chloride in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/00)

more

Eudralex Volume 3 Questions and Answers on Benzoic Acid and Benzoates in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/00)

more

Eudralex Volume 3 Questions and Answers on Benzyl alcohol in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/00)

more

Eudralex Volume 3 Questions and Answers on Ethanol in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/00)

more

The IPEC Certificate of Analysis Guide for Pharmaceutical Excipients 2013

This document provides guidance for the preparation and use of a Certificate of Analysis for pharmaceutical excipients.

more

The IPEC Significant Change Guide for Pharmaceutical Excipients 2014

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

more

Eudralex Volume 3 Quality Working Party questions and answers on API mix

This document provides information on how mixtures of active pharmaceutical ingredient and excipients (API mix) are considered in a marketing authorisation procedure.

more

Eudralex Volume 3 Sterilisation of the medicinal product, active substance, excipient and primary container

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.

more

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK