IPEC publishes GDP Audit Guideline for Pharmaceutical Excipients

Recommendation
Tuesday, 23 September 2025 13.00 - 17.00 h
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
Related GMP News
12.08.2025GDP Implementation Survey: Brief Summary
12.08.2025Storing Medicinal Products Outdoors? Not a good Idea!
15.07.2025New Swissmedic Technical Interpretation on Returns of Medicinal Products
15.07.2025Two new GDP Non-Compliance Reports from Austria and Ireland published in the EudraGMDP database
15.07.2025Reminder: Participate in the GDP Implementation Survey until 31 July 2025
15.07.2025PDA Publishes Results of Transportation Validation Benchmarking Survey