Hmpc guideline on gacp doc

2. 
GENERAL 
2.1 
This document is intended to address the specific concerns of growing, collecting and 
primary processing of medicinal plants/herbal substances that are used for medicinal 
purposes. It addresses specific issues associated with agricultural production and 
collection of medicinal plants/herbal substances in the wild. These considerations 
should be read in connection with GMP guidelines for APIs and should apply to all 
methods of production including organic production in accordance with regional and/or 
national regulations. These provide addit ional standards for the production and 
processing of medicinal plants/herbal substances insofar as they mainly focus on 
identifying those critical production steps that are needed to ensure good quality. 
2.2 
The main aim is to ensure consumer safety by establishing appropriate quality standards 
for medicinal plants/herbal substances. Especially important aspects are that medicinal 
plants/herbal substances: 
- 
are produced hygienically, in order to reduce microbiological load to a minimum, 
- 
are handled with care so that medicinal plants/herbal substances are not adversely 
affected during collection, cultivation, processing and storage.
During the course of the production process medicinal plants/herbal substances and 
their preparations are exposed to a large number of microbiological and other 
contaminants. This Guideline provides recommendations for producers to reduce 
contamination to a minimum. 
1
The term “herbal substance” should be considered as equivalent to the term “herbal drug” as defined in the 
European Pharmacopoeia 
2
The term “herbal preparation” should be considered as equivalent to the term “herbal drug preparation” as 
defined in the European Pharmacopoeia 

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EMEA 2006 
4/11 
2.3 
Considerations and recommendations in this Guideline are intended for all participants 
from primary producers to traders and processors. 
Therefore, producers, traders and processors of medicinal plants/herbal substances 
should comply with these considerations, document all relevant activities in batch 
documentation and demand that their partners do likewise, unless it can be justified 
otherwise. 
Growers and collectors of medicinal plants/herbal substances must ensure that they 
avoid damage to existing wildlife habitats. CITES (Convention on International Trade in 
Endangered species of Wild Fauna and Flora) must be adhered to.