IPEC Good Distribution Practices (GDP) Guide for Pharmaceutical Excipients

Date

January 18, 2025

Category

EU Regulations, US Regulations

Description

IPEC Federation announces the publication and availability of a comprehensive update to the IPEC Good Distribution Practices Guideline for Pharmaceutical Excipients (version 3, 2024), jointly developed by a team consisting of members from IPEC Europe and IPEC-Americas.

After a three-months exclusivity period for IPEC members, the IPEC GDP Guide can be downloaded free of charge on the IPEC Federation and regional IPEC websites.

Excipients play a critical role in the manufacture of medicines by helping to preserve the efficacy, safety, and stability of active pharmaceutical ingredients (APIs), and help to ensure that they deliver their promised benefits to patients.

The IPEC Good Distribution Practices Guideline has proven to be an important element in the supply chain management and control of pharmaceutical starting materials. The updated guide provides a comprehensive tool for companies operating within the supply chain of pharmaceutical excipients. Several serious incidents in the past, and more recently over the past two years resulted in the deaths of many children caused by a lack of supply chain security, inappropriate handling of pharmaceutical excipients and falsification of records. This has moved regulators, users, manufacturers and distributors to take action.

It is IPEC Federation’s position that those involved throughout the entire supply chain for the distribution of pharmaceutical excipients as well as stakeholders should rigorously promote and apply the principles of Good Distribution Practices (GDP) as provided in this updated Guideline.

IPEC Federation strongly believes that the application of GDP by all stakeholders in the excipient supply chain will help to avoid incidents resulting from the use of sub-standard excipients in drug products as described above.

To Know More Please Visit at: Guidelines