Manufacture of herbal medicines

The Committee was informed that the supplementary guidelines on GMP for the manufacture of herbal medicines had been reviewed and updated over recent years through an extensive consultation process. The Committee adopted the document with minor editorial corrections (Annex 3). 

---

Anon. Good Manufacturing Practices Supplementary Guidelines for the Manufacture of Herbal Medicinal Products. WHO Technical Report Series No. 863. Geneva, Switzerland World Health Organization, 1996 109-113. 

Manufacture of immunological veterinary medical products Manufacture of medicinal gases Manufacture of herbal medicinal products Sampling of starting and packaging materials Manufacture of liquids, creams, and ointments Manufacture of pressurized metered-dose aerosol preparations for inhalation... 

Official standards are absolutely necessary to ensure the quality, reliability, and homogeneity of herbal products for consumers. Standardized products are paramount to those in healthcare planning to conduct clinical research with these products. Independent laboratories and university-affiliated research reports have documented the considerable variation that exists in terms of quality and reliability in these products. Abroad, the ESCOP, composed of manufacturers of herbal medicines and herbal associations, is working with European research groups to develop quality-control standards for the production of natural products. This committee is developing monographs for incorporation into such references as the British Herbal Pharmacopoeia and the British Herbal Compendium. 

The first guideline addresses special quality issues of herbal products because of the difference to products containing chemically pure, well-defined active substances. This document should be read in conjunction with Annex 7 Manufacture of Herbal Medicinal Products of Volume 4 of the Rules governing Medicinal Products in the EU. GMP recommendations should be respected and consistent quality can only be assured when... 

Supplementary guidelines on good manufacturing practices (GMP) for heating, ventilation and air-conditioning (HVAC) systems (new. Annex 2). Supplementary guidelines on GMP for the manufacture of herbal medicines (revision. Annex 3). 

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 the country s actual situation. 

Because of the inherent complexity of naturally grown medicinal plants and the often variable nature of cultivated ones, the examples of contamination with toxic medicinal plants and/or plant parts and the number and small quantity of defined active ingredients, the production and primary processing has a direct influence on the quality of herbal medicines. For this reason, application of GMPs in the manufacture of herbal medicines is an essential tool to assure their quality. 

Suitable methods for the determination of possible pesticide contamination and the acceptable limits for such contamination in herbal materials or herbal preparations used in the manufacture of herbal medicines. 

Good Manufacturing Practices supplementary guidelines for the manufacture of herbal medicinal products. In WHO Expert Committee on Specifica-... 

Good Manufacturing Practices for the Manufacture of Herbal Medicinal... 

Because of their often complex and variable nature, and the number and small quantity of defined active ingredients, control of starting materials, storage and processing assume particular importance in the manufacture of herbal medicinal products. 

MANUFACTURE OF HERBAL MEDICINAL PRODUCTS INCLUDING HOMEOPATHIC PRODUCTS... 

GACP, GMP and GLP standards. During the industrial manufacturing of herbal medicinal products not only the raw material is subject to rigid quality control, but also the quality of the semi-manufactured and finished product is monitored (in-process controls) and evaluated (end controls on content, identity, purity). Finally a pharmaceutical dosage form should comply with the applicable pharmacopoeial standards (e.g., crush strength of tablets, disintegration time of tablets and capsules, uniformity of mass and content [11-13]). 

Laasonen, M., Near-Infrared Spectroscopy, a Quality Control Tool for the Different Steps in the Manufacture of Herbal Medicinal Products, Dissertation Abstracts International, 64, 688 (2003). 

---