Guidelines on good manufacturing practices for the manufacture of herbal medicines
Introduction:
In line with the publication of the revised World Health Organization (WHO) guidelines on Good manufacturing practices for pharmaceutical products: main principles (1), supporting and supplementary guidelines were developed to address specific issues connected with the manufacture of certain types of pharmaceutical product. As part of this series, the WHO Supplementary guidelines for the manufacture of herbal medicinal products (2) were issued in 1996. The guidelines were also reproduced in the second volume of the WHO compendium on Quality assurance of pharmaceuticals (3). Related WHO documents such as Guidelines for the assessment of herbal medicines (4), General
guidelines for methodologies on research and evaluation of traditional medicine (5), Quality control methods for medicinal plant materials (6, 7), Guidelines on good agricultural and collection practices for medicinal plants (8), WHO guidelines on assessing quality of herbal medicines with reference to contaminants and residues(9), WHO guidelines for selecting marker substances of herbal origin for quality control of herbal medicines (10) and WHO guidelines on good herbal processing practices for herbal medicines (11) were also issued.
WHO’s Good manufacturing practices: main principles for pharmaceutical products were updated in 2003 (1, 12). Around the turn of the millennium, various product-specific good manufacturing practice (GMP) guidelines covering herbal medicines were developed by a number of WHO Member States, and by the European Union. They covered several issues relevant to the production and quality control of herbal medicines in more detail. For this reason, within the framework of the WHO Traditional Medicine Strategy: 2000–2005, revision of the existing supplementary guidelines was considered desirable; this was also endorsed by the WHO Expert Committee on Pharmaceutical Specifications at its meetings in 2002, 2003, 2004 and 2005. WHO’s Good manufacturing practices: main principles for pharmaceutical products were further updated in 2013 (13).
These new guidelines are intended to complement those provided in Good manufacturing practices for pharmaceutical products (1, 13) and should be read in conjunction with the parent guide. The additional standards addressed by the present guidelines should therefore be considered supplementary to the general requirements (13). They relate specifically to the production and control of herbal medicines, in so far as they mainly focus on identifying the critical steps needed to ensure good quality. The emendation of the text was recommended by the Expert Committee on Specifications for Pharmaceutical Preparations at its fifty-second meeting in 2017 to ensure consistency with the current terminology used and to update the references cited.
The supplementary guidelines are intended to provide WHO Member States with general and minimum technical requirements for quality assurance and control in the manufacture of herbal medicines. Each Member State should develop its own national GMP for manufacturing herbal medicines that are appropriate to its particular situation.
These guidelines deal exclusively with herbal medicines. They do not cover combination of herbal materials with animal materials, mineral materials, chemicals and other substances.
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Table of Contents
1. Quality assurance in
the manufacture of herbal medicines
2. Good manufacturing
practice for herbal medicines
4. Qualification and
validation
7. Contract production
and analysis
16. Good practices in
production
WHO TRS (Technical Report Series) 1010, 2018 Annex 2:
