Official Standards

Official Standards
The requirements stated in the monographs of the Pharmacopoeia apply to articles that are intended for medicinal use but not necessarily to articles that may be sold under the same name for other purposes. An article intended for medicinal use that is described by means of an official title must comply with the requirements of the relevant monograph. A formulated preparation must comply throughout its assigned shelf-life (period of validity). The subject of any other monograph must comply throughout its period of use.
A monograph is to be construed in accordance with any general monograph or notice or any appendix, note or other explanatory material that is contained in this edition and that is applicable to that monograph. All statements contained in the monographs, except where a specific general notice indicates otherwise and with the exceptions given below, constitute standards for the official articles. An article is not of pharmacopoeial quality unless it complies with all of the requirements stated. This does not imply that a manufacturer is obliged to perform all the tests in a monograph in order to assess compliance with the Pharmacopoeia before release of a product. The manufacturer may assure himself that a product is of pharmacopoeial quality by other means, for example, from data derived from validation studies of the manufacturing process, from in-process controls or from a combination of the two. Parametric release in appropriate circumstances is thus not precluded by the need to comply with the Pharmacopoeia. The general notice on Assays and Tests indicates that analytical methods other than those described in the Pharmacopoeia may be employed for routine purposes.
Requirements in monographs have been framed to provide appropriate limitation of potential impurities rather than to provide against all possible impurities. Material found to contain an impurity not detectable by means of the prescribed tests is not of pharmacopoeial quality if the nature or amount of the impurity found is incompatible with good pharmaceutical practice.
The status of any statement given under the headings Definition, Production, Characteristics, Storage, Labelling or Action and use is defined within the general notice relating to the relevant heading. In addition to any exceptions indicated by one of the general notices referred to above, the following parts of a monograph do not constitute standards: (a) a graphic or molecular formula given at the beginning of a monograph; (b) a molecular weight; (c) a Chemical Abstracts Service Registry Number; (d) any information given at the end of a monograph concerning impurities known to be limited by that monograph; (e) information in any annex to a monograph. Any statement containing the word 'should' constitutes non-mandatory advice or recommendation.
The expression 'unless otherwise justified and authorised' means that the requirement in question has to be met, unless a competent authority authorises a modification or exemption where justified in a particular case. The term 'competent authority' means the national, supranational or international body or organisation vested with the authority for making decisions concerning the issue in question. It may, for example, be a licensing authority or an official control laboratory. For a formulated preparation that is the subject of monograph in the British Pharmacopoeia any justified and authorised modification to, or exemption from, the requirements of the relevant general monograph of the European Pharmacopoeia is stated in the individual monograph. For example, the general monograph for Tablets requires that Uncoated Tablets, except for chewable tablets, disintegrate within 15 minutes; for Calcium Lactate Tablets a time of 30 minutes is permitted.
Many of the general monographs for formulated preparations include statements and requirements additional to those of the European Pharmacopoeia that are applicable to the individual monographs of the British Pharmacopoeia. Such statements and requirements apply to all monographs for that dosage form included in the Pharmacopoeia unless otherwise indicated in the individual monograph.
Where a monograph on a biological substance or preparation refers to a strain, a test, a method, a substance, etc., using the qualifications 'suitable' or 'appropriate' without further definition in the text, the choice of such strain, test, method, substance, etc., is made in accordance with any international agreements or national regulations affecting the subject concerned.