Update of IPEC Guide Certificate of Analysis for Pharmaceutical Excipients

The International Pharmaceutical Excipients Council Federation, (IPEC Federation) announces the availability of the updated IPEC Certificate of Analysis Guide for Pharmaceutical Excipients (Version 2, 2022). The guide was originally published in 2013.  This guide is widely used globally.

The primary goal of the guide is meant to provide best practices for the preparation and appropriate use of a Certificate of Analysis (COA) for pharmaceutical excipients. The goal is to standardize the content and suggest a format for COAs for excipients, and to clearly define the roles and responsibilities for the excipient manufacturer and distributor.

In addition to minor editorial changes, other changes include:

• Clarification of key points (e.g., retest date, identification testing, compendial compliance)
• Updating from an IPEC-Americas/IPEC Europe to an IPEC Federation guide, including more global verbiage and references (e.g., pharmacopoeial, skip lot testing)
• Removal for acceptability of company codes in lieu of identity and address of original manufacturing site.
• Addition of a section for COA verification by medicinal product manufacturers.
• Updated COA model (Annex 1)

 DOWNLOAD THE COA GUIDE FOR FREE HERE

IPEC Federation asbl
The Federation of the International Pharmaceutical Excipients Council
Rue Marie de Bourgogne 52 – 1000 Brussels

Source: Press release IPED Federation