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In some monographs, particularly those on excipients, a list of functionality-related characteristics that are relevant to the use of the substance may be appended to the monograph for information. Unless otherwise indicated in the monograph, the requirements apply to all grades of the material. Certain materials that are the subject of a pharmacopoeial monograph may exist in different grades suitable for different purposes. With the agreement of the competent authority, the choice of tests performed to assess compliance with the Pharmacopoeia when animal tests are prescribed, is established in such a way that animal usage is minimised as much as possible. In demonstrating compliance with the Pharmacopoeia as indicated above (1), manufacturers may consider establishing additional systems to monitor consistency of production. (3) Reduction of animal testing: the European Pharmacopoeia is dedicated to phasing out the use of animals for test purposes, in accordance with the 3Rs (Replacement, Reduction, Refinement) set out in the European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes. Real-time release testing in circumstances deemed appropriate by the competent authority is thus not precluded by the need to comply with the Pharmacopoeia. (2) An enhanced approach to quality control could utilise process analytical technology (PAT) and/or real-time release testing (including parametric release) strategies as alternatives to end-product testing alone. The manufacturer may obtain assurance that a product is of Pharmacopoeia quality on the basis of its design, together with its control strategy and data derived, for example, from validation studies of the manufacturing process. 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. (1) An article is not of Pharmacopoeia quality unless it complies with all the requirements stated in the monograph. In the event of doubt or dispute, the methods of analysis of the Pharmacopoeia are alone authoritative.ĭemonstration of compliance with the Pharmacopoeia With the agreement of the competent authority, alternative methods of analysis may be used for control purposes, provided that the methods used enable an unequivocal decision to be made as to whether compliance with the standards of the monographs would be achieved if the official methods were used. The tests and assays described are the official methods upon which the standards of the Pharmacopoeia are based. The quality system must assure that the articles consistently meet the requirements of the Pharmacopoeia.Īlternative methods. The quality standards represented by monographs are valid only where the articles in question are produced within the framework of a suitable quality system. 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). 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. Unless otherwise indicated in the General Notices or in the monographs, statements in monographs constitute mandatory requirements. 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. The subject of any other monograph must comply throughout its period of use. Such references to monographs in the texts of the Pharmacopoeia are shown using the monograph title and reference number in italics.Ī preparation must comply throughout its period of validity a distinct period of validity and/or specifications for opened or broached containers may be decided by the competent authority. The use of the title or the subtitle of a monograph implies that the article complies with the requirements of the relevant monograph. may be used to indicate the European Pharmacopoeia. In the texts of the European Pharmacopoeia, the word 'Pharmacopoeia' without qualification means the European Pharmacopoeia. In case of doubt or dispute, the English and French versions are alone authoritative.
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Translation in other languages may be prepared by the signatory States of the European Pharmacopoeia Convention. The official texts of the European Pharmacopoeia are published in English and French. The General Notices apply to all monographs and other texts of the European Pharmacopoeia.