Direct Links to important GMP Excipient Guidelines

The IPEC Risk Assessment Guide for Pharmaceutical Excipients Part 1 - Risk Assessment for Excipient Manufacturers 2017

This document provides practical guidance on how to perform risk assessments for excipients.

The IPEC Good Distribution Practices Guideline - Updated version

This document provides guidance on Good Distribution Practice for those companies involved in the supply chain of pharmaceutical excipients.

The Joint IPEC-PQG Good Manufacturing Practices Guideline - Updated version

This document covers the quality management system and the extent of GMP required for the manufacture of excipients intended for use in drug products.

PIC/S GUIDELINES ON THE FORMALISED RISK ASSESSMENT FOR ASCERTAINING THE APPROPRIATE GOOD MANUFACTURING PRACTICE FOR EXCIPIENTS OF MEDICINAL PRODUCTS FOR HUMAN USE

PIC/S Guide for determation of the risks from exipients

The IPEC Technically Unavoidable Particle Profile (TUPP) Guide 2015

This document provides guidance on the GMP compliant handling of technically unavoidable particles in excipients.

Eudralex Volumen 2C Guideline on Excipients in the labelling and package leaflet of medicinal products for human use (March 2018)

Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668)

The IPEC Good Distribution Practices Guide for Pharmaceutical Excipients

This guidance document offers best practice for excipient Good Distribution Practices (GDP).

The IPEC Validation Guide for Pharmaceutical Excipients

This document provides guidance on the validation of excipient processes and product.

The IPEC Excipient Information Package User Guide and Template - Part IV: Sustainability Overview

This document is part of the IPEC Excipient Information Package User Guide and provides guidance in the implementation of an excipient sustainability information package.

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