IPEC publishes GDP Audit Guideline for Pharmaceutical Excipients

Recommendation

22/23 February 2024
Munich, Germany

API Regulatory Starting Materials
Definition, Manufacture, Assessment and handling post-approval Changes

The IPEC Good Distribution Practice (GDP) Audit Guideline for Pharmaceutical Excipients has been revised and the new version has been published. The previous version was published in 2008. The original version goes back to 2000.

The new document is designed in a questionnaire format to assist in evaluating the practices and quality systems of distributors who sell, store or repackage pharmaceutical excipients or any combination thereof. The audit guideline should be considered as the audit tool used in the evaluation of excipient distributors' GDP compliance, in accordance with the current IPEC GDP Guideline for Pharmaceutical Excipients (2006), which describes these principles in detail

Source: IPEC Press Release

Here you will find the IPEC Good Distribution Practice (GDP) Audit Guideline for Pharmaceutical Excipients

You can download the word version of the Guide here