IPEC Certificate of Analysis Guide for Pharmaceutical Excipients Now Published

IPEC Certificate of Analysis Guide for Pharmaceutical Excipients Now Published

The IPEC Certificate of Analysis Guide for Pharmaceutical Excipients, 2013 is now available for download from IPEC-Americas website. This guide offers best practice and guidance on the content of an excipient Certificate of Analysis (CoA) and was developed by representatives of many of the member companies of the International Pharmaceutical Excipients Council, an industry association whose members consist of excipient manufacturers, distributors and companies that use excipients in finished drug formulations (users).

The guide is meant to serve as a format for the preparation and use of a CoA for pharmaceutical excipients. The goal is to standardize the content and suggest a format for COAs for excipients, and to define the roles and responsibilities for the excipient manufacturer and distributor. This foundation for mutual understanding will serve as an important element of the overall supply chain controls need to provide the user with assurance of excipient conformance to specification and suitability for use in pharmaceuticals.

The original guide was first published in 2000, however, changes in the global pharmaceutical industry and regulatory area have necessitated its revision. The guide is a collaboration by excipient makers, distributors, and users from IPEC-Americas Excipient Qualification and IPEC Europe’s Quality/Regulatory Affairs committees and it will be provided to the United States Pharmacopoeia for their consideration in revising general Chapter <1080> Bulk Pharmaceutical Excipients – Certificate of Analysis, which is currently based on the earlier guide.

To download a free copy of the guide, please visit IPEC-Americas website at www.ipecamericas.org and visit the “IPEC Store”. Registration is required.