British Pharmacopoeia 2012 Free Download Pdf
Adeline Lynady
The British Pharmacopoeia (BP) is the national pharmacopoeia of the United Kingdom. It is an annually published collection of quality standards for medicinal substances in the UK, which 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 British Pharmacopoeia is an important statutory component in the control of medicines, which complements and assists the licensing and inspection processes of the UK's Medicines and Healthcare products Regulatory Agency (MHRA). Together with the British National Formulary (BNF), the British Pharmacopoeia defines the UK's pharmaceutical standards.
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. Inclusion of a substance in a pharmacopoeia does not indicate that it is either safe or effective for the treatment of any disease.
The British Pharmacopoeia is published on behalf of 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 (EC) 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 regardless of the existence of actual or potential patent rights. Where substances are protected by letters patent, their inclusion in the pharmacopoeia neither conveys, nor implies, licence to manufacture.
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 Medicines Act 1968[2] established the legal status of the British Pharmacopoeia Commission, and of the British Pharmacopoeia, 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 Commission is also responsible for selecting and devising British Approved Names.
Since its first publication in 1864, the distribution of the British Pharmacopoeia has grown throughout the world and 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; in other countries, such as South Korea, the BP is recognised as an acceptable reference standard.[3]
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).
The British Pharmacopoeia is available as a printed volume and electronically in both on-line 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.
The British Pharmacopoeia is prepared by the Pharmacopoeial Secretariat, working in collaboration with the British Pharmacopoeia 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.
Detailed information and guidance on various aspects of current pharmacopoeial policy and practice is provided in supplementary chapters of the British Pharmacopoeia. This includes explanation of the basis of pharmacopoeial specifications, and information on the development of monographs including guidance to manufacturers.
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 British Approved Names, since 2002, may be assumed to be the recommended International Non-proprietary Name (rINN), except where otherwise stated. A World Health Organization (WHO) INN 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.
There are equivalent pharmacopoeia in many other countries, such as U.S. (the United States Pharmacopoeia),[4] Japan (Japanese Pharmacopoeia), and China (Pharmacopoeia of the People's Republic of China). The World Health Organization maintains The International Pharmacopoeia.[5]
The British National Formulary (BNF)[6] and its related publications contain information on prescribing, indications, side effects and costs of all medication available on the National Health Service.
BRITISH PHARMACOPOEIA COMMISSION, 2016. Acacia. In: British Pharmacopoeia Commission. British Pharmacopoeia. [online]. London: TSO. Available from: -pharmacopoeia-com.ezproxy.rgu.ac.uk/bp-2016/monographs/acacia.html?date=2016-01-01 [Accessed 18 January 2016].
Professor Kevin Taylor has been the Chair of the British Pharmacopoeia Commission (BPC) for the past 2 terms. Here he shares some of the highlights and achievements of his successful 8-year period as Chair.
Very early on in my time as Chair, the BP celebrated its 150th anniversary with a very well attended meeting, which ran over several days, and a reception held at the House of Lords. This was a great opportunity to meet with delegates from many international pharmacopoeias, to discuss future developments in quality standards and to think about how the pharmacopoeial community might work together effectively in the future. Mostly though, it was a joyous celebration of 150 years of achievements for the BP nationally and internationally.
Another highlight has been attending the meetings of the European Pharmacopoeia Commission in Strasbourg (pandemic permitting) as a member of the UK delegation. These meetings are always interesting and can sometimes be very challenging, due to differences of pharmacopoeial traditions and practices between the member states. The UK is an enthusiastic participant in these meetings and in the work of the European Pharmacopoeia more generally. It is great to be able to contribute to developing medicines standards at the wider European level, to share the BP experience, and to meet with, and learn from, other delegations. These visits to Strasbourg have also provided a better opportunity to get to know, and share ideas with, some of my fellow BP Commissioners and members of BP staff.
Thinking about the many changes and developments at the BP during my time as Chair, highlights include the great improvements to the BP website over the years, and the way the BP has forged an international reputation for leading on pharmacopoeial developments in new areas, such as developing standards for biological medicines and analytical quality by design.
The BPC is responsible for preparing new editions of the BP and BP (Vet). In practice, this means that Commission members work with the BP Secretariat to ensure that each edition of the BP is produced in a timely manner, and that published standards are up to date, useful, and usable. The BP contains legally enforceable quality standards for medicinal products, sold and supplied in the UK - hence it is a key component of the regulatory framework that ensures that prescribed medicines and those purchased from a pharmacy or supermarket are safe and efficacious. The monographs and testing methods of the BP support the development and quality control of medicines, including for some herbal and unlicensed medicines. Patients, industry, and the NHS are key stakeholders for the BP, and for this reason applicants to the BP Commission from hospital and industry sectors are actively encouraged. Two lay members are also appointed.
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