Good Pharmacopoeial Practices. WHO Technical Report Series, No. 996, 2016, Annex 1
(2016; 20 pages)

Abstract

A pharmacopoeia’s core mission is to protect public health by creating and making available public standards to help ensure the quality of medicines. Pharmacopoeia standards support regulatory authorities in controlling the quality of pharmaceutical substances, their finished pharmaceutical products (FPPs) and related materials and will provide a tool with which the user or procurer can make an independent judgement regarding quality, thus safeguarding the health of the public.

Today there are 49 pharmacopoeias in the world (according to the World Health Organization (WHO) list of pharmacopoeias, 2015). There are differences between these pharmacopoeias, including the use of technology reflected in each pharmacopoeia as well as the breadth of medicines and other articles included. Pharmacopoeias are embedded in their respective national or regional regulatory environment and reflect specifications approved by the regulatory body. Efforts towards pharmacopoeial harmonization started more than a century ago. When WHO was created in 1948, this was included in its mandate. This led to the creation of The International Pharmacopoeia, which was the first global pharmacopoeial activity.

The primary objective of the GPhP guidance is to define approaches and policies in establishing pharmacopoeial standards with the ultimate goal of harmonization. These GPhP describe a set of principles that provide guidance for national pharmacopoeial authorities (NPAs) and regional pharmacopoeial authorities (RPAs) that facilitates the appropriate design, development and maintenance of pharmacopoeial standards. Although the principles may also apply to other products, the focus of these good practices is pharmaceutical substances and FPPs.

 
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