WHO TRS (Technical Report Series) 1010, 2018 Annex 7


WHO TRS (Technical Report Series) 1010, 2018 Annex 7

Good pharmacopoeial practices: Chapter on monographs on herbal medicines


Following the fiftieth meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations, the guidance on good pharmacopoeial practices (GPhP) was published as Annex 1 to the report. The primary objective of the GPhP is to define approaches and policies in establishing pharmacopoeial standards with the ultimate goal of harmonization. In line with this objective, this guidance for monographs on herbal medicines has been developed outlining the structure and contents of a herbal medicine monograph.

1. Introduction:

Pharmacopoeial monographs for herbal medicines should contain information in the definition that is consistent with the monograph title, followed by specifications for quality including identity, purity and content. Individual monographs describe test procedures, together with the corresponding specifications. The monograph may include:

■ an official title;

■ a definition;

■ a production section;

■ an identification section;

■ a test section covering, for example, physicochemical tests and, where appropriate, tests on contaminants;

■ an assay section on determining constituents with known therapeutic activity, active or analytical markers. Further sections providing information on labelling and storage may also be provided.

Click on the following title for full details: pdf

Table of Contents

WHO TRS (Technical Report Series) 1010, 2018 Annex 7:

Post a Comment


Post a Comment (0)