TOPICS : 02- QUALITY, SAFETY & ENVIRONMENT  / 09. Does the EDQM provide Certificates of Analysis for Ph. Eur. reference standards? 

The Ph. Eur. does not provide any certificates of analysis for the European Pharmacopoeia reference standards. The specific case of pharmacopoeial reference standards has been officially recognized in the ‘ISO Guide 34:2009 General requirements for the competence of reference material producers’. European Pharmacopoeia reference standards are officially certified by the European Pharmacopoeia Commission, which adopts the reports establishing their suitability for the intended use.

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