This document provides an overview of the general notices and provisions that apply to all monographs and texts within the European Pharmacopoeia. Some key points include:
- The general notices establish mandatory requirements for all substances and preparations described in monographs to ensure they meet Pharmacopoeia quality standards.
- General monographs on dosage forms and excipients apply broadly, though individual monographs may impose additional requirements.
- Terms like "competent authority" and "unless otherwise justified" are defined to provide conventions for interpreting requirements.
- Alternative analytical methods may be used with agreement from the competent authority.
This document provides an overview of the general notices and provisions that apply to all monographs and texts within the European Pharmacopoeia. Some key points include:
- The general notices establish mandatory requirements for all substances and preparations described in monographs to ensure they meet Pharmacopoeia quality standards.
- General monographs on dosage forms and excipients apply broadly, though individual monographs may impose additional requirements.
- Terms like "competent authority" and "unless otherwise justified" are defined to provide conventions for interpreting requirements.
- Alternative analytical methods may be used with agreement from the competent authority.
This document provides an overview of the general notices and provisions that apply to all monographs and texts within the European Pharmacopoeia. Some key points include:
- The general notices establish mandatory requirements for all substances and preparations described in monographs to ensure they meet Pharmacopoeia quality standards.
- General monographs on dosage forms and excipients apply broadly, though individual monographs may impose additional requirements.
- Terms like "competent authority" and "unless otherwise justified" are defined to provide conventions for interpreting requirements.
- Alternative analytical methods may be used with agreement from the competent authority.
01/2005:10100 functionality-related characteristics that are important for the
use of the substance may be appended to the monograph for information. Test methods for determination of one or more 1.1. GENERAL STATEMENTS of these characteristics may be given, also for information. The General Notices apply to all monographs and other texts General monographs. Substances and preparations that are of the European Pharmacopoeia. the subject of an individual monograph are also required The official texts of the European Pharmacopoeia are to comply with relevant, applicable general monographs. published in English and French. Translations in other Cross-references to applicable general monographs are not languages may be prepared by the signatory States of the normally given in individual monographs. European Pharmacopoeia Convention. In case of doubt General monographs apply to all substances and preparations or dispute, the English and French versions are alone within the scope of the Definition section of the general authoritative. monograph, except where a preamble limits the application, In the texts of the European Pharmacopoeia, the word for example to substances and preparations that are the Pharmacopoeia without qualification means the European subject of a monograph of the Pharmacopoeia. Pharmacopoeia. The official abbreviation Ph. Eur. may be General monographs on dosage forms apply to all used to indicate the European Pharmacopoeia. preparations of the type defined. The requirements are not The use of the title or the subtitle of a monograph implies necessarily comprehensive for a given specific preparation that the article complies with the requirements of the and requirements additional to those prescribed in the relevant monograph. Such references to monographs in the general monograph may be imposed by the competent texts of the Pharmacopoeia are shown using the monograph authority. title and reference number in italics. Conventional terms. The term competent authority A preparation must comply throughout its period of validity ; means the national, supranational or international body or a distinct period of validity and/or specifications for opened organisation vested with the authority for making decisions or broached containers may be decided by the competent concerning the issue in question. It may, for example, be a authority. The subject of any other monograph must comply national pharmacopoeia authority, a licensing authority or throughout its period of use. The period of validity that is an official control laboratory. assigned to any given article and the time from which that The expression unless otherwise justified and authorised period is to be calculated are decided by the competent means that the requirements have to be met, unless the authority in the light of experimental results of stability competent authority authorises a modification or an studies. exemption where justified in a particular case. Unless otherwise indicated in the General Notices or in Statements containing the word should are informative or the monographs, statements in monographs constitute advisory. mandatory requirements. General chapters become In certain monographs or other texts, the terms suitable mandatory when referred to in a monograph, unless such and appropriate are used to describe a reagent, reference is made in a way that indicates that it is not the intention to make the text referred to mandatory but rather micro-organism, test method etc. ; if criteria for suitability are not described in the monograph, suitability is demonstrated to cite it for information. to the satisfaction of the competent authority. The active ingredients (medicinal substances), excipients (auxiliary substances), pharmaceutical preparations and Interchangeable methods. Certain general chapters contain other articles described in the monographs are intended a statement that the text in question is harmonised with for human and veterinary use (unless explicitly restricted the corresponding text of the Japanese Pharmacopoeia to one of these uses). An article is not of Pharmacopoeia and/or the United States Pharmacopeia and that these texts quality unless it complies with all the requirements are interchangeable. This implies that if a substance or stated in the monograph. This does not imply that preparation is found to comply with a requirement using an performance of all the tests in a monograph is necessarily interchangeable method from one of these pharmacopoeias a prerequisite for a manufacturer in assessing compliance it complies with the requirements of the European with the Pharmacopoeia before release of a product. The Pharmacopoeia. In the event of doubt or dispute, the text of manufacturer may obtain assurance that a product is of the European Pharmacopoeia is alone authoritative. Pharmacopoeia quality from data derived, for example, from validation studies of the manufacturing process and from 01/2005:10200 in-process controls. Parametric release in circumstances deemed appropriate by the competent authority is thus not 1.2. OTHER PROVISIONS APPLYING precluded by the need to comply with the Pharmacopoeia. TO GENERAL CHAPTERS AND The tests and assays described are the official methods upon which the standards of the Pharmacopoeia are based. MONOGRAPHS With the agreement of the competent authority, alternative Quantities. In tests with numerical limits and assays, the methods of analysis may be used for control purposes, quantity stated to be taken for examination is approximate. provided that the methods used enable an unequivocal The amount actually used, which may deviate by not more decision to be made as to whether compliance with the than 10 per cent from that stated, is accurately weighed standards of the monographs would be achieved if the official methods were used. In the event of doubt or dispute, or measured and the result is calculated from this exact quantity. In tests where the limit is not numerical, but usually the methods of analysis of the Pharmacopoeia are alone depends upon comparison with the behaviour of a reference authoritative. in the same conditions, the stated quantity is taken for Certain materials that are the subject of a pharmacopoeial monograph may exist in different grades suitable for different examination. Reagents are used in the prescribed amounts. purposes. Unless otherwise indicated in the monograph, Quantities are weighed or measured with an accuracy the requirements apply to all grades of the material. In commensurate with the indicated degree of precision. For some monographs, particularly those on excipients, a list of weighings, the precision corresponds to plus or minus 5 units General Notices (1) apply to all monographs and other texts