10/11 October 2023
IPEC-Americas (Europe's counterpart of the European Association for Pharmaceutical Excipients, IPEC Europe) has recently published a new guideline on audits of excipients suppliers. This guideline replaces the corresponding document from 2000. The "Good Distribution Practices Audit Guide for North American Distribution of Pharmaceutical Excipients" was elaborated following the WHO Guide "Good Trade and Distribution Practices for Pharmaceutical Starting Materials" with a similar composition. A tabular checklist presents questions on the respectively important departments and fields of an excipients supplier which is helpful for an audit. The scope of the document includes all GMP relevant steps beginning from the moment when a pharmaceutical excipient leaves the controlled area of the material management system of the original manufacturer. This should support the auditor in his decision-making with regard to in-depth detail and focus of his audit.
The fact that North America is mentioned in the title of the guideline doesn't mean that its content is only specific to the American continent. IPEC Americas has simply taken over the proven standards from the WHO-Guide and IPEC Europe's "Good Distribution Practices Guide" and published the document as a recommendation for the American clientele.
For further details please see the IPEC Americas' new Guide.
Note: Audits of the excipients supply chain and the certification scheme of IPEC Europe will be central topics of the conference "GMPs for Pharmaceutical Excipients" which will take place in Barcelona, Spain, from 27-28 September 2011.
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)