Revised IPEC GDP Audit Guide for Pharmaceutical Excipients Available to the General Public

Recommendation

13/14 December 2023

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In September 2021, the International Pharmaceutical Excipients Council Federation (IPEC Federation) announced the availability of the revised IPEC Good Distribution Practices Audit Guide for Pharmaceutical Excipients (Version 3, 2021). After the guide was initially only accessible exclusively to IPEC members for three months, the document was now made available to the general public.

The revised guide has been developed by a team consisting of members from IPEC Europe and IPEC-Americas. The document is a consolidation and revision of IPEC Europe’s GDP Audit guideline (2011) and IPEC-Americas GDP Audit Guide for North American distribution of pharmaceutical excipients (2011).

According to the authors, the document represents voluntary guidance for the excipient industry and the contents should not be interpreted as regulatory requirements. The guide was created to help companies understand current expectations.

Content of the Document

The 44-page document is designed in the form of a questionnaire. The following GDP relevant areas are covered:

• Quality Management
• Organisation and Personnel
• Premises
• Procurement, warehousing and storage
• Equipment
• Documentation
• Repackaging and relabeling
• Complaints
• Recalls
• Returned Goods
• Handling of Non-conforming Materials
• Dispatch and Transport
• Contract activities