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Type: Reference work
Subject: Chemistry, medicine, pharmacy, veterinary
The European Pharmacopoeia (Ph. Eur.) is a reference work and an authoritative collection of standards for the quality control of medicines. It provides public standards for the quality of medicinal products and their constituents which are legally binding in Europe.
European Pharmacopoeia is produced by the European Directorate for the Quality of Medicines & HealthCare (EDQM) and defines requirements for the qualitative and quantitative composition of medicines. This also includes control of the tests to be carried out on medicines and on substances and materials used in their production.
The requirements are legally binding in the member states of the European Pharmacopoeia Convention and the European Union.
Hence the official quality standards in the European Pharmacopoeia must be applied by the producers of medicines and substances for pharmaceutical use.
The European Pharmacopoeia covers:
Furthermore it includes texts on biologicals, blood and plasma derivatives, vaccines and radiopharmaceutical preparations.
The European Pharmacopoeia is widely used internationally. There is a growing need to develop global quality standards for medicines as a result of the globalisation and expansion in international trade.
The refernce work is appropriate to the needs of:
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