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The European Pharmacopoeia: setting quality standards for Europe and beyond and supplying pharmaceutical reference standards [ edit ] Published and regularly updated by the EDQM/ Council of Europe in English and French, the two official languages of the Council of Europe, the Ph. Eur. is a compendium of official quality standards for medicines ...
The quality standards of the European Pharmacopoeia apply throughout the entire life-cycle of a product, and become legally binding and mandatory on the same date in all thirty-nine (39) signatory states, which include all European Union member states. Several legal texts make the European Pharmacopoeia mandatory in Europe. [1]
Pharmacopoeial reference standards are a subset of pharmaceutical reference standards. They are established for the intended use described in pharmacopeial texts (monographs and general chapters). Pharmacopeial reference standards are available from various pharmacopoeias such as United States Pharmacopeia and the European Pharmacopoeia. Where ...
USP establishes documentary (written) and reference (physical) standards for medicines, food ingredients, dietary supplement products, and ingredients. These standards are used by regulatory agencies and manufacturers to help to ensure that these products are of the appropriate identity, as well as strength, quality, purity, and consistency.
Pharmacopoeial standards are publicly available and legally enforceable standards of quality for medicinal products and their constituents. The British Pharmacopoeia is an important statutory component in the control of medicines, which complements and assists the licensing and inspection processes of the UK's Medicines and Healthcare products ...
European Standards (abbreviated EN, from the German name Europäische Norm ("European Norm")) [1] [2] are technical standards drafted and maintained by CEN (European Committee for Standardization), CENELEC (European Committee for Electrotechnical Standardization) and ETSI (European Telecommunications Standards Institute).
This is an incomplete list of DIN standards. The "STATUS" column gives the latest known status of the standard . If a standard has been withdrawn and no replacement specification is listed, either the specification was withdrawn without replacement or a replacement specification could not be identified.
This is a list of published [Note 1] International Organization for Standardization (ISO) standards and other deliverables. [Note 2] For a complete and up-to-date list of all the ISO standards, see the ISO catalogue. [1] The standards are protected by copyright and most of them must be purchased.