Direct Links to important GMP Excipient Guidelines

Qualification of Excipients for Use in Pharmaceuticals Guide & Checklist

This document provides guidance on how to qualify pharmaceutical excipients.

The Joint IPEC-PQG Good Manufacturing Practices Audit Guideline 2008

This document provides standards for audits in Excipients production sites

The Joint IPEC-PQG Good Manufacturing Practices Guideline

This document provides guidance for appropriate GMP standards in the manufacture of pharmaceutical excipients.

The IPEC Good Distribution Practices Audit Guideline For Pharmaceutical Excipients 2021

This document describes standards for Good Distribution Practice Audits of pharmaceutical excipients.

Eudralex Volume 3 CHMP/CAT position statement on Creutzfeldt-Jakob disease and advanced therapy medicinal products

The composition of ATMPs may include components of human origin (either as active ingredient, excipients, or raw materials used in their manufacture) and, therefore, the risk of transmitting CJD or vCJD agents has to be considered. Current status of related guidelines

The IPEC Excipient Stability Program Guide

This document provides guidance for establishing a stability study program for a pharmaceutical excipient.

FDA Guidance for Industry: Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products

This guidance provides the pharmaceutical industry with the Center for Drug Evaluation and Research’s (CDER’s) current thinking on the potential human health risks associated with exposure to dibutyl phthalate (DBP) and di(2-ethylhexyl) phthalate (DEHP

Eudralex Volume 3 Questions and answers on cyclodextrins 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)

Eudralex Volume 3 Questions & answers on propylene glycol and esters 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)

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)

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