IPEC: Version 3 of GDP Guide available
Recommendation
Thursday, 13 February 2025 10.30 - 15.45 h
Focus on CADIFA and obtaining a Brazilian GMP certificate
In January 2025, version 3 of the IPEC guide "Good Distribution Practices Guide for Pharmaceutical Excipients" was published on the IPEC website (International Pharmaceutical Excipients Council Europe (IPEC Europe) asbl). The guide had been available to members in the IPEC member area since October 2024 and can now be viewed in in the "Resources" section of the "Guidelines" area.
The new version's table of contents looks like this:
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 matches the directory of the previous 2017 version, although subsections 1.1-1.3 have been added.
Version 3 of the "Good Distribution Practices Guide for Pharmaceutical Excipients" and the previous version of 2017 can be found on the IPEC website after initial registration.
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