Pharmacopoeial Compendia

Galbraith Laboratories provides analytical services to many of the tests in the United States Pharmacopeia, European Pharmacopoeia and Japanese Pharmacopoeia.

United States Pharamcopeia – National Formulary (USP/NF)

The United States Pharmacopeia–National Formulary is a book of public pharmacopeial standards. It contains standards for medicines, dosage forms, drug substances, excipients, medical devices, and dietary supplements.

The U.S. Federal Food, Drug, and Cosmetics Act designates the USP–NF as the official compendia for drugs marketed in the United States. A drug product in the U.S. market must conform to the standards in USP–NF to avoid possible charges of adulteration and misbranding. The USP–NF is also widely used by manufacturers wishing to market therapeutic products worldwide. Meeting USP–NF standards is accepted globally as assurance of high quality.

[Courtesy of http://www.usp.org/USPNF/]

Japanese Pharmacopoeia (JP)

The Japanese Pharmacopoeia provides the official Japanese standard for the description and quality of drug substances and products.

The Japanese, United States and European Pharmacopoeias are the major pharmacopoeias in the world. They have established regular lines of communication and have set up a program that is working towards the harmonization of monographs and standards.

[Courtesy of http://www.rt-corp.com/products/c305.aspx]

European Pharmacopoeia (EP)

The European Pharmacopoeia is a listing of a wide range of active substances and excipients used to prepare pharmaceutical products in Europe. The 2005 edition includes 1800 specific and general monographs, including various chemical substances, antibiotics, biological substances; Vaccines for human or veterinary use; Immunosera; Radiopharmaceutical preparations; Herbal drugs; Homoeopathic preparations and homoeopathic stocks. It also contains Dosage forms, General monographs, Materials and Containers, Sutures; 268 General methods with figures or chromatograms and 2210 reagents are described.

[Courtesy of http://en.wikipedia.org/wiki/European_Pharmacopoeia]

On 22 July 1964, Belgium, France, Germany, Italy, Luxembourg, the Netherlands, Switzerland and the United Kingdom signed a Convention, under the auspices of the Council of Europe, on the elaboration of a European Pharmacopoeia.

The objectives are to harmonize specifications for medicinal substances which are of general interest to the peoples of Europe and to hasten the drawing-up of specifications for the growing number of new medicinal substances appearing on the market.

These objectives are attained by creating a European Pharmacopoeia made up of monographs which become official standards applicable in the territories of the Contracting States.

On 16 November 1989 a Protocol to the Convention was signed which enabled the European Community to accede to the Convention. The Protocol entered into force on 1 November 1992.

A total of 32 European countries are now party to the Convention:

  • The 15 Member States of the European Union and the European Community itself;
  • Three EFTA countries (Island, Norway & Switzerland);
  • Seven of the ten acceding states (Cyprus, Czech Republic, Estonia, Hungary, Latvia, Slovakia & Slovenia);
  • Two of the three candidate countries (Romania & Turkey);
  • Finally, Bosnia and Herzegovina, Croatia, Serbia and Montenegro and the Former Yugoslav Republic of Macedonia.

The European Pharmacopoeia is drawn up by two bodies:

  • The European Pharmacopoeia Commission is responsible for preparing and adopting technical decisions on the monographs. It consists of eminent scientists appointed by each of the Contracting Parties for their competence;
  • The Public Health Committee of the Council of Europe administratively oversees the Commission’s activities and, in particular, lays down the date for implementation of the monographs, although it may not alter any of their technical content.

[Courtesy of http://europa.eu/scadplus/leg/en/lvb/l21161.htm]