International Pharmacopoeia

Overview

The International Pharmacopoeia (Ph. Int.) is published by WHO. It consists of a collection of recommended procedures for analysis and specifications for determining pharmaceutical substances, excipients and dosage forms, that is intended to serve as source material for reference or adapation by any WHO Member State wishing to establish pharmaceutical requirements. Its fundamental aim is global harmonization of quality specifications for selected pharmaceutical products, excipients and dosage forms.

History

The first volume of Ph.Int. was published in 1951. Initially it encompassed all the medicines that were available and sold globally. Since 1975 it has focused on medicines included in the WHO Model List of Essential Medicines, and, more recently, on priority medicines of major public health importance, including those recommended by specific WHO disease programmes for treating malaria, tuberculosis and HIV/AIDS, as well as medicines for children. Priority is also given to medicines evaluated by the WHO Prequalification Team.

Process

The work on The International Pharmacopoeia is carried out in collaboration with members of the WHO Expert Advisory Panel on The International Pharmacopoeia and WHO Expert Committee on Specification for Pharmaceutical Preparations and with other specialists. The process involves consultation with and gathering of input from WHO Member States medicines regulatory authorities and national medicines quality control laboratories, WHO collaborating Centres, standard-setting organizations and manufacturers around the world.