IPEC-Americas releases GDP Audit Guide
For North American distribution of pharmaceutical excipients
The IPEC-Americas GDP Audit Guide is designed to be used by distributors, brokers, and traders of excipients primarily in North America, but can also be used as a resource for auditing distributors globally.
The guide, produced by the IPEC-Americas GMP Committee, applies to all steps in the supply chain, beginning where the excipient is outside the control of the original manufacturer’s material management system.
The Audit Guide can be used as an audit checklist, or as a tool to assist with determination of the focus and scope of an auditIt can also be used with IPEC’s Good Distribution Practices Guide for Pharmaceutical Excipients (2006).
The guide begins with a Matrix of Applicability that defines GDP activities that may apply to the particular distribution operation being assessed. Activities include transportation of both packed and bulk excipients and relabelling. This matrix then defines the applicability of 13 audit sections (complaints, recalls, quality management) associated with each type of GDP activity. A Greek letter identifies the applicability.
By identifying the particular distribution operation being assessed and its associated applicability, the auditor can then create a customised audit checklist by selecting from the numerous open-ended questions covering more than 95 categories contained within the 13 quality audit sections.
Additional information, including a pdf copy of the Audit Guide, is available on the IPEC-Americas website.