WHO TRS (Technical Report Series) 996, 2016 Annex 1

WHO TRS (Technical Report Series) 996, 2016 Annex 1

Good pharmacopoeial practices

1. Background:

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. Many others followed.

Pharmacopoeial harmonization has been defined by the Pharmacopoeial Discussion Group (PDG) as “when a pharmaceutical substance or product tested by the document’s harmonized procedure yields the same results and the same accept/reject decision is reached”.

Developments in science and medical practice, globalization and the presence of spurious/falsified/falsely labelled/counterfeit (SFFC) products require pharmacopoeias to continuously revise their monographs and other text. Harmonization and reinforced collaboration among pharmacopoeial committees and regulators, supported by adequate interaction with industry, will assist in facing new challenges and resource constraints.

The first initiative to reopen the discussion on international harmonization of quality control specifications on a global scale was taken in a side meeting of the 10th International Conference of Drug Regulatory Authorities (ICDRA) entitled: “Pharmacopoeial Specifications – Need for a Worldwide Approach?” in Hong Kong on 24 June 2002. This led to further discussions among regulators during the 11th ICDRA meeting held in Madrid in 2004. Other international events during the following years enabled discussions with and among pharmacopoeias on this topic.

The main suggestion emerging from all these events was the development of  good pharmacopoeial practices (GPhP) to encourage harmonization, facilitated by WHO.

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WHO TRS (Technical Report Series) 996, 2016 Annex 1:

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