EUROPEAN PHARMACOPOEIA 5.

1. General notices

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