Updated IPEC guide: Qualification of Excipients for Use in Pharmaceuticals

Category: IPEC Federation
  • 15 Dec 2020

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The International Pharmaceutical Excipients Council Federation, (IPEC Federation) announces the availability of the thoroughly revised and updated IPEC Qualification of Excipients for Use in Pharmaceuticals Guide and Checklist (Version 2, 2020). The guide was originally published in 2008. This guide is widely used globally.

The primary goal of the Qualification of Excipients for Use in Pharmaceuticals Guide and Checklist is to identify the minimum information needed to support the marketing of materials for use as excipients as well as their use by pharmaceutical companies.

The checklist was developed as a quick reference for topics to consider during the qualification of an excipient for use in medicinal products.

The guide and the template will be available, initially exclusively to IPEC members for a three-month period, on the IPEC Federation and national/regional members’ websites.
Thereafter, the guide and the template will be made available to the general public.


Are you an IPEC Europe MemberDownload the Guideline free of charge on the Member's Lab.
You can find detailed instructions here.
If you do not have access to the Member's Lab yet, please contact the Secretariat.