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European Pharmacopoeia, Reference Standards & Certificate of Suitability

European Pharmacopoeia, Reference Standards & Certificate of Suitability
Product Description

The European Pharmacopoeia (Ph. Eur.) is the official pharmacopoeia in Europe, providing legally binding quality standards (monographs) for medicinal products. These monographs ensure that any impurities resulting from the manufacturing process are identified and suitably controlled, so that the medicines produced are not harmful to patients. Ph. Eur. reference standards (RSs) are essential for carrying out the quality control tests described in the Ph. Eur. and comprise chemical reference substances (CRSs), herbal reference standards (HRSs) and biological reference preparations (BRPs). The Certification procedure is the process by which manufacturers of pharmaceutical substances covered by a monograph may obtain a Certificate of suitability to the monographs of the European Pharmacopoeia (CEP).

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EDQM

  • Country/Region:
    France
  • On CPHI since:
    2015
  • Employees:
    250 - 499
Company types
Other
Primary activities
Other
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EDQM

  • Country/Region:
    France
  • On CPHI since:
    2015
  • Employees:
    250 - 499
Company types
Other
Primary activities
Other
View company profile

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    The Certification procedure is the process by which manufacturers of pharmaceutical substances covered by a monograph may obtain a Certificate of suitability to the monographs of the European Pharmacopoeia (CEP).

    Book a private, one-to-one session with the Certification team to ...
  • European Pharmacopoeia 12th Edition

    Product European Pharmacopoeia 12th Edition

    The European Pharmacopoeia (Ph. Eur.) is the primary source of official quality standards (monographs) for medicines and their ingredients in Europe. These monographs provide a legal and scientific basis for the quality control of a product throughout its life cycle, supporting the pharmaceutical indust...
  • Ph. Eur. Reference Standards

    Product Ph. Eur. Reference Standards

    Ph. Eur. reference standards (RSs) are essential for carrying out the quality control tests described in the Ph. Eur. and comprise chemical reference substances (CRSs), herbal reference standards (HRSs) and biological reference preparations (BRPs). 

    https://store.edqm.eu/index.html

EDQM resources (2)