EUROPEAN PHARMACOPOEIA 7TH EDITION PDF

The European Pharmacopoeia has a legally binding character. It is used as an official reference to serve public health , [1] and is part of the regulatory requirements for obtaining a Marketing Authorisation MA for a medicinal human or veterinary product. Several legal texts make the European Pharmacopoeia mandatory in Europe. All manufacturers of medicines or substances for pharmaceutical use therefore must apply the European Pharmacopoeia quality standards in order to be able to market and use these products in Europe.

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Liliane Sthefanie flag Denunciar. This correction has been taken into account in the 7th Edition. These general monographs give requirements that are applicable to all products in the given class or, in some cases, to any product in the given class for which there is a specific monograph in the Pharmacopoeia see 1. General Notices, General monographs. Where no restriction on scope of a general monograph is given in a preamble, it is applicable to all products in the class defined, irrespective of whether there is an individual monograph for the product in the Pharmacopoeia.

Whenever a monograph is used, it is essential to ascertain whether there is a general monograph applicable to the product in question. The general monographs listed below are published in the section General Monographs unless otherwise stated. This list is updated where necessary and republished in each Supplement. The official texts of the European Pharmacopoeia are published in English and French.

Translations in other languages may be prepared by the signatory States of the European Pharmacopoeia Convention. In case of doubt or dispute, the English and French versions are alone authoritative. The official abbreviation Ph. The use of the title or the subtitle of a monograph implies that the article complies with the requirements of the relevant monograph. Such references to monographs in the texts of the Pharmacopoeia are shown using the monograph title and reference number in italics.

The subject of any other monograph must comply throughout its period of use. The period of validity that is assigned to any given article and the time from which that period is to be calculated are decided by the competent authority in light of experimental results of stability studies. Unless otherwise indicated in the General Notices or in the monographs, statements in monographs constitute mandatory requirements.

General chapters become mandatory when referred to in a monograph, unless such reference is made in a way that indicates that it is not the intention to make the text referred to mandatory but rather to cite it for information.

The active substances, excipients, pharmaceutical preparations and other articles described in the monographs are intended for human and veterinary use unless explicitly restricted to one of these uses. An article is not of Pharmacopoeia quality unless it complies with all the requirements stated in the monograph. This does not imply that performance of all the tests in a monograph is necessarily a prerequisite for a manufacturer in assessing compliance with the Pharmacopoeia before release of a product.

The manufacturer may obtain assurance that a product is of Pharmacopoeia quality from data derived, for example, from validation studies of the manufacturing process and from in-process controls. Parametric release in circumstances deemed appropriate by the competent authority is thus not precluded by the need to comply with the Pharmacopoeia.

The tests and assays.

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Sitemap Links. Stay connected. Rechercher :. The European Pharmacopoeia Ph. It covers active substances, excipients and preparations of chemical, animal, human or herbal origin, homoeopathic preparations and homoeopathic stocks, antibiotics, as well as dosage forms and containers. It also includes texts on biologicals, blood and plasma derivatives, vaccines and radiopharmaceutical preparations. The European Pharmacopoeia and its requirements are legally binding in the member states of the European Pharmacopoeia Convention and the European Union.

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European Pharmacopoeia 7th Edition Volume 1

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