What is the BP?

The BP has been providing official standards for medicines since 1864, and provides the only comprehensive collection of authoritative official standards for UK pharmaceutical substances and medicinal products, including all the monographs and texts of the European Pharmacopoeia (Ph. Eur.).

Pharmacopoeias that have legal status within the UK are the British Pharmacopoeia (BP), including the BP (Veterinary), and the Ph. Eur. The BP is published every year in August, and becomes legally effective on January 1st of the following year. 

Description

The British Pharmacopoeia has provided official standards for the quality of substances, medicinal products and articles used in medicine since its first publication in 1864. It is used in over 100 countries and remains an essential global reference in pharmaceutical research and development and quality control. This book explores how these standards have been achieved through a comprehensive review of the history and development of the pharmacopoeias in the UK, from the early London, Edinburgh and Dublin national pharmacopoeias to the creation of the British Pharmacopoeia and its evolution over 150 years. Trade in medicinal substances and products has always been global, and the British Pharmacopoeia is placed in its global context as an instrument of the British Empire as it first sought to cover the needs of countries such as India and latterly as part of its role in international harmonisation of standards in Europe and elsewhere. The changing contents of the pharmacopoeias over this period reflect the changes in medical practice and the development of dosage forms from products dispensed by pharmacists to commercially manufactured products, from tinctures to the latest monoclonal antibody products. The book will be of equal value to historians of medicine and pharmacy as to practitioners of medicine, pharmacy and pharmaceutical analytical chemistry

What we do

The BP makes an important contribution to the role of the Medicines and Healthcare products Regulatory Agency (MHRA) in protecting public health by providing quality standards for UK pharmaceutical substances and medicinal products. It is a vital reference tool for all individuals and organisations involved in pharmaceutical:

• research
• development
• manufacture
• quality control and analysis

The BP has a wide international reach and:

• is used in over 100 countries
• forms an inherent part of established medicines legislation in Commonwealth countries
• provides expert advice to the European Pharmacopoeia and plays a significant role in the standard-setting process in Europe
• provides expert advice to the World Health Organization
• has strong links with leading world pharmacopoeias, ensuring the quality of medicines is always at the forefront of international discussio

• 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 what is now known as the British Pharmacopoeia was published in 1864, and was one of the first attempts to harmonise pharmaceutical standards, through the merger of the London, Edinburgh and Dublin Pharmacopoeias. The Neo-Latin name that had some currency at the time was Pharmacopoeia Britannica (Ph. Br.).

  In 1844, concern about the dangers of unregulated manufacture and use led William Flockhart – who had provided chloroform to Doctor (later Sir) James Young Simpson for his experiment on anaesthesia – to recommend the creation of a 'Universal Phamacopoeia for Great Britain' in his inaugural speech as president of the Northern British branch of the Pharmaceutical Society.^[1]

  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 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.

  .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
  • Homeopathic Preparations

  Volume IV

  • Appendices
  • Infrared Reference Spectra
  • Index

  Volume V

  • British Pharmacopoeia (Veterinary)

  Volume VI: (CD-ROM version)

  • British Pharmacopoeia
  • British Pharmacopoeia (Veterinary)
  • British Approved Names

  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.

What is U.S. Pharmacopeia (USP)?

 

About the U.S. Pharmacopeia (USP)

USP is an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines. We are working to strengthen the global supply chain so that the medicines people rely on for health are available when needed and work as expected.

For over 200 years, USP has worked to build trust where it matters most: in the world's medicines, dietary supplements and foods. Through our rigorous science and the public quality standards we set, USP helps protect patient safety and improve the health of people around the world.

Diversity, equity, inclusion and belonging at USP: Empowering a healthier tomorrow

USP aspires to be a diverse, inclusive, innovative, and engaging organization that empowers and engages staff and volunteers to contribute to its mission to improve global health. We are committed to creating a culture where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, family status, and where they can contribute their full potential to accomplish our mission.

Our focus on Diversity, Equity and Inclusion is intentional and designed to build a sense of true Belonging. USP’s Office of Organizational Culture, Equity & Inclusive Excellence works across the organization to ensure global staff and volunteers are equipped to understand, embrace, and integrate the principles of diversity, equity, inclusion, and belonging to achieve USP’s mission (in a way relevant to their role, function, and business processes). Additionally, USP’s vibrant Affinity Network, comprised of 11 affinity groups globally, helps drive inclusion and belonging at USP by creating a safe space for support, sharing, connection, and professional development. This network works towards increasing staff member engagement, retention and fostering a more inclusive work environment.

Governance

USP is governed by three bodies composed entirely of volunteers from around the world: the USP Convention membership, the Board of Trustees, and the Council of Experts and its Expert Committees. 

USP Convention Membership

With a mission to improve global health through public standards, it’s essential that USP be guided by broad and diverse perspectives. From the thousands of expert volunteers who have given their time to develop USP standards to the nearly 450 Convention Member Organizations committed to helping shape USP’s areas of focus, USP always prioritizes an independent and collaborative approach to its work. 

To this end, the Convention Membership represents perspectives, experiences, and expertise from across healthcare and science and from around the globe. Member Organizations are vital to USP’s ability to sustain its pivotal role in building trust where it matters most: in the world’s medicines, dietary supplements, and foods.

Board of Trustees

USP’s work is critical, complex, and rapidly evolving. Our Board of Trustees, responsible for USP’s sustainability, is comprised of experienced leaders and respected experts. Together they provide guidance and oversight that help sustain and expand USP’s impact on public health.

Council of Experts and its Expert Committees

USP standards are essential to supporting a more resilient supply of quality medicines. It’s the Council of Experts that oversees USP’s scientific and standards-setting decisions, each chairing one of USP’s Expert Committees. These leaders from around the world contribute their time, expertise, and passion to helping advance USP’s mission.

What is the European Pharmacopoeia?

 

European Pharmacopoeia - Background and Mission

Background

The European Pharmacopoeia is a single reference work for the quality control of medicines in the signatory states of the Convention on its elaboration.

The official standards published within provide a legal and scientific basis for quality control during the development, production and marketing processes.

They concern the qualitative and quantitative composition and the tests to be carried out on medicines, on the raw materials used in production of medicines and on the intermediates of synthesis. All producers of medicines and/or substances for pharmaceutical use must therefore apply these quality standards in order to market their products in the signatory states of the Convention.

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Legal Framework

Several legal texts make the European Pharmacopoeia mandatory. These are as follows:

• the Convention developed by the Council of Europe on the Elaboration of a European Pharmacopoeia,
• a Protocol adopted in 1994 and amending the Convention to prepare for the accession of the European Union and defining the respective powers of the European Union and its member states within the European Pharmacopoeia Commission,
• European Union Directive 2001/83/EC as amended, on medicines for human use and and Regulation (EU) 2019/6 on veterinary medicinal products. These maintain the mandatory character of European Pharmacopoeia monographs when requesting marketing authorisation (MA).

The contracting parties of the Convention undertake to:

• progressively elaborate a Pharmacopoeia which shall become common to the countries concerned and which shall be entitled "European Pharmacopoeia"
• take the necessary measures to ensure that the monographs shall become the official standards applicable within their country by direct implementation in the national legislation or by indirect implementation through national translation.

For information about the working procedure and the functions of the different bodies responsible for carrying out the work of elaborating a European Pharmacopoeia, please consult the documents in the right-hand menu.

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Mission

The purpose of the European Pharmacopoeia is to promote public health by the provision of recognised common standards for the quality of medicines and their components. Such standards are to be appropriate as a basis for the safe use of medicines by patients. In addition, their existence facilitates the free movement of medicinal products in Europe and beyond.

European Pharmacopoeia monographs and other texts are designed to be appropriate to the needs of:

• regulatory authorities;
• those engaged in the quality control of medicinal products and their constituents;
• manufacturers of medicinal products and their individual components.

The European Pharmacopoeia is widely used internationally. As globalisation and expansion in international trade present a growing need to develop global quality standards for medicines, the Commission works closely with all users of the Pharmacopoeia worldwide.

COLOUR

The EP Colour Standards were originally visual colour standards intended to improve colour communication between sites by defining a sample colour as being close to a physical liquid standard ("near EP Y2") rather than using the words "light yellow".

EP consists of 3 primary colour standard solutions (yellow, red, blue) that are combined with hydrochloric acid to make 5 standard solutions that when further diluted with hydrochloric acid (10 mg/l) make 37 reference EP standards; Red (R1 - R7); Yellow (Y1 - Y7); Brown (B1 - B9); Brown/Yellow (BY1 - BY7); Green/Yellow (GY1 - GY7).

The procedure for manufacturing these standards is time consuming and tedious and the stock solutions must be stored in a cool dark place in order to remain colour constant. It is for these reasons that standards of a more stable nature were in demand. Thus a series of Lovibond® colour discs were originally developed to represent this scale.

An alternative to the visual methods is now available as a program in the Lovibond® PFX and PFXi ranges of spectrocolorimeters. Measurements are based on specific wavelengths for each of the various pharmacopoeia colour scales (US and Chinese Pharmacopoeia are local alternatives.)

Types of pharmacopeia?

 

List of Pharmacopoeia

A. United States Pharmacopeia

Its INN system symbol is USP. The USP is issued in a combination with the National Formulary as the USP-NF. The USP is an official compendium for drugs marketed in the U.S. and annually published by the United States Pharmacopeial Convention. To avoid probable charges of adulteration and misbranding, a drug product in the U.S.A market must conform to the standards in http://USP–NF.

The USP provides monographs for drug substances, compounded preparations, and dosage forms are presented in the USP. Monographs for dietary supplements and ingredients are presented in a distinct section of the USP. The USP-NF contains excipient monographs.

On 15th December 1820, the first edition of United States Pharmacopeia was published in both English and Latin. It was published annually since 2002. The First National Formulary of the U.S. appeared in 1888. In 1992, the electronic version of USP-NF on floppy disks was introduced. USP has laboratories in India, Brazil, China, and the United States.

B. British Pharmacopoeia

Its INN system symbol is BP. Since 1864, BP has been supplying official standards for medicines. It consisted of two sections.

• Part I: – Materia Medica
• Part II: – Preparation & compounds

In 1953, the eighth edition of BP was published. In this edition, titles of drugs and preparations were in English in lieu of Latin and metric systems. Annually BP has been published. In BP 2007 monographs have been presented for material specifically used in the preparation of Traditional Chinese medicines.

The term “Gastro-resistant” has been substituted with “Enteric coated” and the term “Prolonged release” has been substituted for the term “Slow” in the number of monographs. The Pharmacopoeial Secretariat working in collaboration with the British Pharmacopoeia Commission (BPC), the British Pharmacopoeia Laboratory, and its Expert Advisory Groups (EAG) and Advisory Panels has been publishing the British Pharmacopoeia.

C. European Pharmacopoeia

Its INN system symbol is Ph. Eur. It is Europe’s legal and scientific benchmark for pharmacopoeial standards. It helps to deliver high-quality medicines in Europe and beyond. European Pharmacopoeia is a published collection of monographs that describe active and inactive ingredients, methods of analysis for medicines, descriptions of reagents, animal, human or herbal origin, homeopathic stocks, and homeopathic preparations, antibiotics, vaccines as well as dosage forms and containers. It also contains texts on biologicals, blood and plasma derivatives, and radiopharmaceutical preparations. In 1969, the first edition of the Ph. Eur. was published which consisted of 120 texts.

• Book Version: Available in English or French.
• Online Version:  Cumulative, tablet, and smartphone friendly. Bilingual (English and French).
• Downloadable version:   Cumulative and bilingual (English and French).

D. International Pharmacopoeia

The International Pharmacopoeia has been published by the World Health Organization (WHO). Its INN system symbol is Ph. Int. In 1951, the first volume of International Pharmacopoeia was published. The International Pharmacopoeia (Ph. Int.) constitutes a collection of recommended procedures for analysis and specifications for the determination of pharmaceutical substances and dosage forms that are intended to serve as source material for reference or adaptation by any WHO Member State wishing to establish pharmaceutical requirements. The Eighth Edition of The International Pharmacopoeia was published in 2018.

 E. Japanese Pharmacopoeia

Its INN system symbol is JP. The JP (日本薬局方) is the official pharmacopeia of Japan. Pharmaceuticals and Medical Devices Agency under the authority of the Ministry of Health, Labour and Welfare have been published JP. The first edition was published on 25 June 1886, with revisions being issued from time to time. The current revision is number 17, issued electronically in the English language on 7 March 2016. On 25 June 1886, JP was first published and implemented in July 1887 and issued electronically in the English language on 7 March 2016 and JP has been revised periodically.

F. Indian Pharmacopoeia

Its INN system symbol is JP. The IP is the official pharmacopoeia of India. Indian Pharmacopoeia Commission (IPC) has published IP under the authority of the Ministry of Health & Family Welfare, Government of India. For manufacturing, and selling medicine in the Indian market IPC sets standards.

IP-2018 contains 4 Volumes incorporating 220 new monographs (Chemical Monographs (170), Herbal Monographs (15), Veterinary monographs (14), Blood and Blood-related products (10), Biotechnology-Derived Therapeutic Products (06), Radiopharmaceutical monographs (03), Vaccines and Immunosera for Human use monographs (02)) as well as 366 revised monographs and 7 omissions.

G. Chinese Pharmacopoeia

 Its INN system symbol is ChP. The Pharmacopoeia Commission under the authority of the Ministry of Health of the People’s Republic of China has published the Pharmacopoeia of the People’s Republic of China (PPRC) or ChP. ChP is an official compendium of drugs covering traditional Chinese and Western medicines, which includes information but not limited to description, the standards of purity, test, precaution, storage, strength, and dosage for each drug. Also, it is recognized as the official Chinese pharmacopoeia by the WHO.

• Monographs of Volume I deal with Chinese material medica and pared slice, Chinese traditional patent medicines, vegetable oil/fat, and its extract, single ingredient of Chinese crude drug preparations etc.
• Monographs of Volume II contain antibiotics, chemical drugs, biochemical preparations, Radiopharmaceuticals as well as excipients for pharmaceutical use.
• Monographs of Volume III deal with biological products.

 H. Others Pharmacopoeia

1. French Pharmacopoeia
2. Brazilian Pharmacopoeia
3. Czech Pharmacopoeia
4. Mexican Pharmacopoeia
5. Royal Spanish Pharmacopoeia

Book of pharmcopoeis?

 

Pharmacopoeia means ″drug-making″ or ″to make a drug″. This word derives from the ancient Greek (pharmakopoiia), from (pharmako) ″drug″, followed by the verb-stem (poi) ″make″ and finally the abstract noun ending (-ia).

Pharmacopoeia is an official publication describing drugs, chemicals, and medicinal preparations as well as containing directions for compound identification. The word ‘Pharmacopoeia’ is widely used and common spelling but ‘Pharmacopeia’ is used only in USP.

. Pharmacopoeia: British spelling 

. Pharmacopeia: American spelling

Remember that, a detailed written study of a single specialized subject is called a monograph. A monograph contains but not limited to the name of the ingredient, the definition, preparation, storage, packaging, and labeling requirements; and the specifications. The specification contains a series of tests, procedures for the tests, and acceptance criteria. Here is a list of pharmacopoeia:Table of Contents

• List of Pharmacopoeia
  • A. United States Pharmacopeia
  • B. British Pharmacopoeia
  • C. European Pharmacopoeia
  • D. International Pharmacopoeia
  •  E. Japanese Pharmacopoeia
  • F. Indian Pharmacopoeia
  • G. Chinese Pharmacopoeia
  •  H. Others Pharmacopoeia

Who is the founder of Pharmacopoeia?

 

Charles Rice (1841-1901): creator of the modern scientific pharmacopoeia and father of the National Formulary

 Indian Pharmacopoeia Commission (IPC) is an Autonomous Institution of the Ministry of Health and Family Welfare, Govt. of India. IPC is created to set standards of drugs in the country. Its basic function is to update regularly the standards of drugs commonly required for treatment of diseases prevailing in this region. It publishes official documents for improving Quality of Medicines by way of adding new and updating existing monographs in the form of Indian Pharmacopoeia (IP). It further promotes rational use of generic medicines by publishing National Formulary of India. IP prescribes standards for identity, purity and strength of drugs essentially required from health care perspective of human beings and animals. IPC also provides IP Reference Substances (IPRS) which act as a finger print for identification of an article under test and its purity as prescribed in IP.

A pharmacopoeia is a legally-binding collection, prepared by a national or regional authority, of standards and quality specifications for medicines used in that country or region.

Some 60 pharmacopoeias (national, regional and subregional and international) are listed in the index compiled by WHO.

WHO initiated steps based on discussion during meetings of the International Conference of Drug Regulatory Authorities (ICDRA), especially the 10th ICDRA meeting held in Hong Kong in 2002, and a further discussion among regulators during the 11th ICDRA meeting held in Madrid in 2004, to organize an official meeting entitled International meeting of world pharmacopoeias for participation of all WHO Member States' pharmacopoeias worldwide, be they national, regional or international.

What is pharmacopoeia ?

 The pharmacopoeia is an official collection of approved pharmaceutical standards. In addressing anyone who produces, distributes or controls medicinal products it comprises requirements on the quality of medicinal products and of the substances used to manufacture them. Moreover, it provides quality control methods. It is therefore an important component of the drug safety system and thus an instrument for patient and consumer protection. How ever, the trend to outsource the production of raw materials to countries outside Europe is often associated with altered production procedures and may have severe consequences. Unwanted side effects of medicinal products--caused by quality changes of the raw materials--may occur. However, this peril can be significantly reduced by consistently adapting the provisions of the pharmacopoeia to the evolution of the drug market.

In healthcare systems around the world, medicines play an important role in treating illness, preventing disease, and ultimately, saving lives. In a broader sense, medicines are valuable to society as tools to protect the public health. Nowadays, medicines are complex products made from numerous ingredients sourced through the global supply chain. The quality of medicines is ensured by the control of many factors such as the quality of their components. While quality medicines are safe and effective, substandard and falsified medicines can be ineffective and even harmful.

History of pharmacy

 Like all healthcare professions, the origins of pharmacy can be traced back thousands of years. In fact, the earliest pharmaceutical text ever discovered dates to the Mesopotamians in 2100 B.C. 1

From the time our early ancestors realized there were medicinal properties contained within the natural world, there have been people whose role in society was to transform leaves, seeds, bark, insects, and other flora and fauna into medicine. And although very little crushing of tree bark is done in the profession today, you can draw a straight line between these early practitioners and our modern pharmacists.

However, chronicling the history of pharmacy back to multiple ancient civilizations is a bit ambitious, so we’ll start our history a few hundred years prior to our present day.2

India inherited a disorganised pharmacy system from the British authorities when it gained independence in 1947, and there were no legislative constraints on the practise of pharmacy. The 'Pharmacy Act' was enacted in 1948 as the country's first minimum education requirement for pharmacy profession. The Act's provisions are carried out by the 'Pharmacy Council of India(PCI)'. Individual states are required by the Act to create state pharmacy councils that are in charge of overseeing and registering pharmacists in their jurisdictions.

what is pharmacy ?

 

A pharmacist is a healthcare professional who specializes in the preparation, dispensing, and management of medications and who provides pharmaceutical advice and guidance. Pharmacists often serve as primary care providers in the community, and may offer other services such as health screenings and immunizations.

Pharmacists are health care professionals who specialize in the right way to use, store, preserve, and provide medicine. They can guide you on how to use medications and let you know about any potential side effects. They fill prescriptions issued by doctors and other health care professionals.

Pharmacists also contribute to research and testing of new drugs. They work in pharmacies, medical clinics, hospitals, universities, and government institutions.