Europe sets up backup site for reference standards

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Nordroden)
(Image: Getty/Nordroden)

Related tags: European directorate for the quality of medicines, European pharmacopoeia, Reference standards, European union

EQDM opens a second site for European Pharmacopoeia reference standards, used in the quality control of medicines across 120 countries.

The European Directorate for the Quality of Medicines (EDQM) officially opened​ the site on Friday of last week, which will contain contingency stocks of European Pharmacopoeia reference standards.

Explaining the reasoning behind having a second site housing the contingency stock of reference products, the directorate noted that stocks will only be used if there are unexpected disruptions to supply from the first site, based in Strasbourg, France.

The new site will be based in Ars-Laquenexy, France, and will house 3,000 reference standards, which are used and distributed in more than 120 countries. Last year, the EDQM manufactured 1,600,000 vials worth of reference standards for the new site.

The vials are supplied to health authorities, official medicines control laboratories, and pharmaceutical manufacturers, which are able to use the standards to maintain quality standards. For instance, they can be used in identification, purity tests or assays.

In terms of the specifications of the new site, the floor area covers 2,770-square-meters, with 235-square-meters dedication to the preparation of samples required for laboratory studies for the development of monographs and the establishment of reference standards.

The entire site is capable of storing 9,400,000 vials of reference standards.

Related topics: Regulatory & Safety, QA/QC

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