The purpose of the Ph. It provides official quality standards or monographs for medicines and their components that are legally binding in the member states having ratified the Convention on the Elaboration of a European Pharmacopoeia and which are applied in many countries outside Europe.
To elaborate the Ph. They represent national authorities e. The Ph. Commission, the governing body of the Ph. The official Ph.
They are needed to identify the pharmaceutical substance or product tested, determine its content or potency and control impurities that may originate from its manufacturing process. The scientific expertise and the technical equipment of the EDQM Laboratory, to which ISO accreditation attests, ensure that reference standards can be used by all manufacturers and independent control laboratories as a reliable means of controlling the quality of medicines and their ingredients.
It distributes reference standards to users worldwide, to both manufacturers of medicines or pharmaceutical ingredients and public institutions involved in the quality control of medicines. The secondary site of the EDQM, inaugurated in , enables the safe storage of contingency stocks of reference standards and ensures the sustainability and continuity of the supply of pharmaceutical reference standards in the event of major incidents at its main site in Strasbourg.
Links to both of these documents are provided within the database. Standard Terms was originally a printed publication, until the 5th edition, which was published in December alongside an online database. Since April , Standard Terms has only been available as an online database. In November a major new update was introduced with the first version of the database in its current form, and access was made available free of charge for all users after registration with the EDQM Publications registration website.
Further updates to the structure of the database were released in March and in August to add new features, while the content of the database is updated on a continuous basis.
European Pharmacopoeia monographs and other texts are designed to be appropriate to the needs of:. The European Pharmacopoeia is widely used internationally. As globalisation and expansion in international trade present a growing need to develop global quality standards for medicines, the Commission works closely with all users of the Pharmacopoeia worldwide.
Council for europe portal. Language : en Search Choose language. Legal Framework Several legal texts make the European Pharmacopoeia mandatory.
Programme results for Council for europe portal. Language : en Search Choose language.
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