IPEC-Americas Distributors Audit Guide for North American Distribution is now available. This guide replaces an earlier related document published in 2000.

The audit guide is linked to the IPEC Good Distribution Practices Guide (based on the WHO Good Trade and Distribution Practices for Pharmaceutical Starting Materials), and follows the same structure.

It applies to all steps in the distribution/supply chain starting from the point at which an excipient is transferred outside the control of the original manufacturer's material management system. The document is meant to provide a framework for the auditor who must decide to what level of detail and focus the audit must follow. It can also be used as an audit check-list by the distributor/supplier.

To download a copy of this and other IPEC Guidance Documents, please visit the IPEC Store! IPEC members can log in and access the guide directly from the "member resources" tab on the upper navigational bar.