European Pharmacopoeia, Reference Standards & Certificate of Suitability

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).