British Pharmacopoeia
From Wikipedia, the free encyclopedia
Published annually, the British Pharmacopoeia (BP) is a collection of quality standards for UK medicinal substances. It is used by individuals and organisations involved in pharmaceutical research, development, manufacture and testing. Pharmacopoeial standards are publicly available and legally enforceable standards of quality for medicinal products and their constituents. The Pharmacopoeia is an important statutory component in the control of medicines which complements and assists the licensing and inspection processes of the Medicines and Healthcare products Regulatory Agency (MHRA) [1]of the United Kingdom.
Pharmacopoeial standards are compliance requirements, that is, they provide the means for an independent judgement as to the overall quality of an article and apply throughout the shelf-life of a product.
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[edit] Legal basis
The British Pharmacopoeia is published for the Health Ministers of the United Kingdom on the recommendation of the Commission on Human Medicines in accordance with section 99(6) of the Medicines Act 1968 and notified in draft to the European Commission in accordance with Directive 98/34/EEC.
The monographs of the European Pharmacopoeia as amended by Supplements published by the Council of Europe are reproduced either in the British Pharmacopoeia or in the associated edition of the British Pharmacopoeia (Veterinary).
In the Pharmacopoeia certain drugs and preparations are included notwithstanding the existence of actual or potential patent rights. In so far as such substances are protected by Letters Patent their inclusion in the Pharmacopoeia neither conveys, nor implies, licence to manufacture.
[edit] History
The regulation of medicinal products by officials in the United Kingdom dates back to the reign of King Henry VIII (1491–1547). The Royal College of Physicians of London had the power to inspect apothecaries’ products in the London area and to destroy defective stock. The first list of approved drugs with information on how they should be prepared was the London Pharmacopoeia published in 1618. The first edition of the British Pharmacopoeia was published in 1864 and was one of the first attempts to harmonise pharmaceutical standards between different countries, through the merger of the London, Edinburgh and Dublin Pharmacopoeias.
A Commission was first appointed by the General Medical Council (GMC) when the body was made statutorily responsible under the Medical Act 1858 for producing a British Pharmacopoeia on a national basis. In 1907 the British Pharmacopoeia was supplemented by the British Pharmaceutical Codex, which gave information on drugs and other pharmaceutical substances not included in the BP, and provided standards for these.
The 1968 Medicines Act established the legal status of the British Pharmacopoeia Commission and of the BP as the UK standard for medicinal products under section 4 of the Act. The British Pharmacopoeia Commission continues the work of the earlier Commissions appointed by the GMC and is responsible for preparing new editions of the British Pharmacopoeia and the British Pharmacopoeia (Veterinary) and for keeping them up to date. Under Section 100 of the Medicines Act, the British Pharmacopoeia Commission is also responsible for selecting and devising British Approved Names (BANs – see below).
Since its first publication back in 1864 the distribution of the British Pharmacopoeia has grown throughout the world. It is now used in over 100 countries. Australia and Canada are two of the countries that have adopted the BP as their national standard alongside the UK, and in other countries (e.g. Korea) it is recognised as an internationally acceptable standard.
Content
The current edition of the British Pharmacopoeia comprises six volumes which contain nearly 3,000 monographs for drug substances, excipients and formulated preparation, together with supporting General Notices, Appendices (test methods, reagents etc) and Reference Spectra used in the practice of medicine, all comprehensively indexed and cross-referenced for easy reference. Items used exclusively in veterinary medicine in the UK are included in the BP (Veterinary).
Volumes I and II_________Medicinal Substances
Volume III______________Formulated Preparations, Blood related Preparations, Immunological Products, Radiopharmaceutical Preparations Surgical Materials Homoeopathic Preparations
Volume IV______________Appendices Infrared Reference Spectra Index
Volume V______________British Pharmacopoeia (Veterinary)
Volume VI______________CD-ROM version of the British Pharmacopoeia, British Pharmacopoeia (Veterinary) and British Approved Names
The BP is available as a printed volume and electronically in both on-line [2]and CD-ROM versions, the electronic products use sophisticated search techniques to locate information quickly. For example, pharmacists referring to a monograph can immediately link to other related substances and appendices referenced in the content by using 130,000+ hypertext links within the text.
[edit] Production
The BP is prepared by the Pharmacopoeial Secretariat working in collaboration with the BP Laboratory, the British Pharmacopoeia Commission (BPC) and its Expert Advisory Groups (EAG) and Advisory Panels. The development of pharmacopoeial standards receives input from relevant industries, hospitals, academia, professional bodies and governmental sources, both within and outside the UK.
The BP Laboratory provides analytical and technical support to the British Pharmacopoeia. Its major functions are:
Development of new pharmacopoeial monographs – the laboratory undertakes the development and validation of qualitative and quantitative test methods for new BP monograph specifications and refines and revalidates test methods for existing BP monographs.
British Pharmacopoeia Chemical Reference Substances (BPCRS) – the laboratory is responsible for the procurement, establishment, maintenance and sale of BPCRS. The catalogue currently contains nearly 500 BPCRS, which are needed as standards for monograph tests in both the BP and the BP (Veterinary). Detailed information regarding BPCRS is available on the BP Laboratory website [3].
[edit] Guidance
Detailed information and guidance on various aspects of current pharmacopoeial policy and practice is provided in Supplementary Chapters of the BP including explanation of the basis of pharmacopoeial specifications and information on the development of monographs including guidance to manufacturers.
[edit] Availability
The current edition of the British Pharmacopoeia is available from The Stationery Office Bookshop.
[edit] British Approved Names
British Approved Names (BANs) are devised or selected by the British Pharmacopoeia Commission (BPC) and published by the Health Ministers on the recommendation of the Commission on Human Medicines to provide a list of names of substances or articles referred to in section 100 of the Medicines Act 1968. BANs are short, distinctive names, for substances where the systematic chemical or other scientific names are too complex for convenient general use.
As a consequence of Directive 2001/83/EC as amended, the BANs, since 2002, may be assumed to be the recommended International Non-proprietary Name (rINN) except where otherwise stated. An INN [4] identifies a pharmaceutical substance or active pharmaceutical ingredient by a unique name that is globally recognised and in which no party can claim any proprietary rights. A non-proprietary name is also known as a generic name.
[edit] Related publications
There are equivalents in many other countries, such as the United States (USP)[5] and Japan [6], and the World Health Organisation maintains "The International Pharmacopoeia" [7].
The British National Formulary[8] contains information on prescribing, indications, side effects and costs of all medication drugs available on the National Health Service.
[edit] See also
[edit] External links
- British Pharmacopoeia Commission, publisher of the British Pharmacopoeia
