Direct Links to important GMP Excipient Guidelines

The IPEC Excipient Information Package (EIP): Template & User guide 2012

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

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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.

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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.

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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.

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The IPEC Europe Co-processed Excipient Guide for Pharmaceutical Excipients 2017

This Guide is intended to provide support to both manufacturers and users of co-processed excipients and provides recommendations regarding the safety information required for regulatory filing for a product containing a novel co-processed excipient.

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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

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The IPEC Technically Unavoidable Particle Profile (TUPP) Guide 2015

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

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The IPEC Europe 'How-To' Document on EU Guidelines on Risk Assessment for Excipients 2015

This document provides guidance on how to implement a formalised risk assessment for ascertaining the appropriate GMP for excipients according to the requirements of the EU Guideline OJ 2015/C 95/02.

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

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

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GMP Conferences by Topics

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