Ph. Eur. Reference Standards
The EDQM supplies chemical reference substances (CRS) and biological reference preparations (BRP) as well as reference spectra for the tests and assays to be carried out in accordance with the official methods prescribed in the European Pharmacopoeia.
The existence of official reference standards recognised throughout Europe enables national control agencies and manufacturers to avoid costly duplication of work on secondary standards, which could otherwise lead to disagreements among member states and to problems of mutual recognition.
Specific batches of candidate material are selected. These are characterised at the EDQM laboratory using a number of methods including those described in the European Pharmacopoeia and according to the principles of ‘ISO Guide 34:2009 General requirements for the competence of reference material producers'.
Candidate materials can also be the subject of international collaborative studies. Once adopted by the European Pharmacopoeia Commission, official reference standards become available for distribution. They are then used in pharmaceutical analysis, for example, for identification, purity tests or assays.
For reference standards established within the Biological Standardisation Programme (BSP), go to BSP Background & Mission.
The EDQM encourages OMCLs, other medicine control laboratories and industry to get involved in the establishment of its reference standards.
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