Direct Links to important GMP Excipient Guidelines

Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use

Risk assessment for excipients GMP


Composition Guide for Pharmaceutical Excipients

This document offers best practice and guidance in the consideration of an excipient composition profile. The excipient supplier may be a manufacturer or a distributor (or both). The Guide highlights the factors to consider when assessing an excipient composition profile, particularly in the context of Design Space and Quality by Design.


WHO Supplementary guideline for the manufacture of pharmaceutical excipients

WHO definition of GMP requirements for Pharmaceutical excipients


FDA Guidance for Industry Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients

This guideline provides sponsors with guidance on the types of toxicity information the FDA recommends to be provided to the FDA to support the use of new Excipients as components of drug products


WHO Good trade and distribution practices for pharmaceutical starting materials

Guideline with requirements for QS-System, Documentation, Transport, Warehousing, Recalls, Labeling for the handling of pharmaceutical starting materials (API & Excipients)


WHO Good Distribution Practice for pharmaceutical products

WHO Guideline with requirements for distribution of pharmaceutical products (not API & Excipients)


Eudralex Volume 3 Excipients in the Dossier for Application for Marketing Authorisation of a Medicinal Product CHMP/QWP/396951/06

This guideline describes the information that needs to be submitted in relation to excipients including antioxidants and antimicrobial preservatives, in the context of applications for marketing authorisations or variations relating to an excipient in authorised medicinal products.


Eudralex Volume 3 VOLUME 3B Guidelines - Medicinal products for human use. Safety, environment and information: Excipients in the label and package leaflet of medicinal products for human use

This guideline is for use by competent authorities, applicants for a Marketing Authorisation and Marketing Authorisation Holders. The Annex provides a list of the excipients which should be stated on the labelling and outlines the information which should appear in the package leaflet, for these excipients. This guideline does not apply to these substances when they are used as active substances.


Excipient Information Package User Guide and Templates

This document describes the preparation of an information package for pharmaceutical excipients and contains templates for these documents.


The IPEC Quality Agreement Guide and Template(s) 2017

This document provides guidance on how to prepare a Quality Agreement for pharmaceutical excipients and contains a template for it.


GMP Conferences by Topics

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