PQG – IPEC Excipients GMP Guide

The IPEC-PQG Excipients GMPs Guide proposes GMP appropriate for the manufacture of excipients and is a joint initiative between the International Pharmaceutical Excipients Council (IPEC), as IPEC-Americas and IPEC Europe and the Pharmaceutical Quality Group (PQG).  It incorporates the IPEC Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients, 2001 with the PQG’s PS 9100:2002 Pharmaceutical Excipients.

The Guide makes an essential contribution to the wider understanding and attainment of good manufacturing practice appropriate for the excipient supply industry.  Excipient manufacturers and their customers can be assured that excipients manufactured according to this Guide will meet internationally accepted good manufacturing practice principles.

To download the IPEC-PQG Excipients GMPs Guide as a pdf document.  Go to our Downloads page.

A pocket size hard copy version of the Guide is also available to purchase.  Excipient Guide – Order Form for further details and an order form.

The IPEC-PQG Excipients GMPs Guide will eventually be superseded by the Excipact standard being developed by the Excipact consortium including PQG, see Partners Group, Excipact for details.