IPEC: Updated GDP Guide for Excipients

In October 2024, the IPEC (International Pharmaceutical Excipients Council Europe (IPEC Europe) asbl) announced on its website the new version 3 of its GDP guide 'Good Distribution Practices Guide for Pharmaceutical Excipients'. The document is currently only available in the IPEC member area. The updated guide is to be published after a period of three months (probably at the beginning of 2025). It can be assumed that this will be available as usual under the 'Resources' section in the 'Guidelines' area of the IPEC website. You can currently view a summary and table of contents of the revised guide.

The table of contents of the new version is as follows:

1 INTRODUCTION
   1.1 Purpose
   1.2 Scope 
   1.3 Principles Adopted
2 PHARMACEUTICAL GRADE EXCIPIENTS
3 GOOD DISTRIBUTION ACTIVIES FOR PHARMACEUTICAL EXCIPIENTS
Table 1 Matrix of Applicability
Table 2 Applicability for Supply Chain Activities 
   1. Quality Management
   2. Organisation and personnel
   3. Premises
   4. Procurement, warehousing and storage
   5. Equipment
   6. Documentation
   7. Repackaging and relabelling
   8. Complaints
   9. Recalls
  10. Returned Goods
  11. Handling of non-conforming materials
  12. Dispatch and Transport
  13. Contract activities
4 REFERENCES

This largely corresponds to the table of content of the previous version from 2017, although subsections 1.1-1.3 have been added.

The pre-announcement of version 3 of the 'Good Distribution Practices Guide for Pharmaceutical Excipients' and the previous version of the 2017 guide can be found on the IPEC website.