- REFERENCES ....................................................................................................................................... 14
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Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
EMA/HMPC/246816/2005
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EXECUTIVE SUMMARY
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This guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
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1.
- Due to the inherent
complexity of medicinal plants and herbal substances the quality of these starting materials requires an
adequate quality assurance system for the collection and/or cultivation, harvest, and primary
processing.
- (either outdoor, indoor or in greenhouses) should be carefully considered, since each of the mentioned
types could have several problems and advantages.
- The used cultivation method may be dependent on
the final application of the herbal medicinal product.
- primary processing of herbal substances that are used for the preparation of herbal medicinal products.
- medicinal plants and herbal substances, ensuring that they are handled appropriately throughout all
stages of cultivation, collection, processing and storage.
- their preparations are exposed to a large number of environmental contaminants of both biotic and
abiotic origin.
- to existing wildlife habitats and must adhere to CITES (Convention on International Trade in
Endangered species of Wild Fauna and Flora).
- https://health.ec.europa.eu/document/download/bd537ccf-9271-4230-bca1-2d...
4 https://health.ec.europa.eu/document/download/fd318dd6-2404-4e67-82b0232...
3
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EMA/HMPC/246816/2005
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4.
- Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
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8.
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7.
- Where possible, stable varieties and cultivars naturally
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resistant or tolerant to disease should preferably be used.
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The application should be carried out only by qualified staff using approved equipment.
- The following should be noted:
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Damaged plants or plant parts need to be excluded or limited in accordance with a specific
pharmacopoeia monograph, where relevant.
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directly to the sun (except in cases where there is a specific need) and must be protected from
rainfall, insect infestation, etc.
- The label must be clear, permanently fixed and made from
6
Reflection paper on the use of fumigants (EMEA/HMPC/125562/2006)
Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
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non-toxic material.
- Certain exudates that have not been subjected to a specific treatment are
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also considered to be herbal substances.
- European Pharmacopoeia General Monograph ?HERBAL DRUGS? 07/2017:1433
Are obtained by subjecting herbal substances to treatments such as
extraction, distillation, expression, fractionation, purification, concentration
or fermentation.
