WHO TRS (Technical Report Series) 1010, 2018 Annex 1

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WHO TRS (Technical Report Series) 1010, 2018 Annex 1: WHO guidelines on good herbal processing practices for herbal medicines

WHO guidelines on good herbal processing practices for herbal medicines

1. Introduction:

1.1 Background to development of guidelines

1.1.1 Needs

Over the past three decades, there has been a constant, and at times, exponential growth in global interest in the use of herbal medicines. This increase in popularity and usage of herbal medicines is evident in the global market. Herbal medicines, including finished herbal products and the starting materials for their production, such as medicinal plants, herbal materials, herbal preparations and herbal dosage forms, are moving into international commerce and global trade, which reflects their increased economic value and importance.

Adverse events reported to the regulatory authorities in relation to the use of herbal products are often attributable to poor quality of source material and manufacturing and processing factors, among others. Correct identification of source plant species and the selection of appropriate parts for use in herbal medicines are basic and essential steps for ensuring safety, quality and efficacy of herbal medicines. Hence, the safety and quality of herbal medicines at every stage of the production process have become a major concern to health authorities, health care providers, the herbal industries and the public.

The safety and efficacy of herbal medicines largely depend on their quality. Unlike pharmaceutical products formulated from single-molecule chemicals produced synthetically or by isolation from natural source materials employing reproducible methods, herbal medicines consist of simple processed herbs or finished herbal products prepared from source materials containing a multiplicity of chemical constituents, the quality and quantity of which can vary from batch to batch due to intrinsic and extrinsic factors. Consequently, the quality of finished herbal products is greatly influenced by the quality of the raw materials and the intermediates; and the requirements and methods for quality control of finished herbal products, particularly for mixed herbal preparations, are far more complex than those employed for single-molecule chemical medicines.

A number of World Health Assembly (WHA) resolutions relating to traditional medicine have requested the World Health Organization (WHO) to provide technical support to develop methodology to monitor or ensure the safety, quality and efficacy of herbal medicines. The International Conferences of Drug Regulatory Authorities, and annual meetings of International Regulatory Cooperation for Herbal Medicines, as well as the Meetings of the National Centres Participating in the WHO International Drug Monitoring Programme have also requested WHO to develop and continuously update the technical guidelines on quality, safety and efficacy of herbal medicines.

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Table of Contents

1. Introduction

2. Good herbal processing practices for the production of herbal materials

3. Good herbal processing practices for the production of herbal preparations

4. Good herbal processing practices for the production of herbal dosage forms

5. Technical issues supporting good herbal processing practices

6. Other relevant issues 

References

Appendix 1 Example of a model format for a good herbal processing practices monograph/standard operating procedure protocol to produce a herbal material 

Appendix 2 Example of a model format for a good herbal processing practices monograph/standard operating procedure protocol to produce a herbal preparation or herbal dosage form 

Appendix 3 Processing facilities for the post-harvest processing 

Appendix 4 Processing facilities for production of herbal preparations and herbal dosage forms



WHO TRS (Technical Report Series) 1010, 2018 Annex 1:

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