| Sažetak (engleski) | A lot of factors such as temperature, light exposure, water availability, nutritients, period
and site of collection, age and part of plant collected, method of collection, processing
(drying, chemical/radioactive treatment, ... ), storage and distribution of starting herbal
material, etc., can greatly affect the quality and consequently the therapeutic value of
herbal medicines. Therefore, it is essential to produce starting material under Good Agriculture
and Collection Practice (GACP) conditions. Because of plant's genetic and chemical
content variations, the site and date should be recorded for each collection. The production
of starting materials by cultivation would normally lead to more consistent
herbal products due to greater genetic uniformity. Furthermore, cultivation permits monitoring
of active constituents and defining of the best period for harvesting. Whether
field collected from the wild or produced by cultivation, botanical authentication of plant
species and identification by their binomial Latin names are necessary to insure that the
correct herbal material is obtained. Also, care must be taken to free the targeted starting
material of undesirable plant parts, soil, insects, animal excreta and other contaminants.
During post-collection treatments microbial, agrochemical residues and toxic metals
contamination should be reduced to a minimum. The harvested starting material must
be processed to produce the finished herbal product under Good Manufacture Practices
(GMPs) which are similar to those employed for the manufacture of conventional drugs.
Frequent variability in the composition of herbally based medicines can be avoided by
proper standardization of herbal drugs/preparations and their quality control using
pharmacopoeial and/ or validated testing methods. ln the cases where the active principles
are unknown, marker substance(s) should be established for analytical purposes. lndependently
on traditional use of HMP, all data concerning the quality ))from the seeds
to the final product« should be provided in the application dossier for marketing authorisation.
Post-marketing surveillance by regulatory agencies is further pivotal step in the
permanent quality assurance of HMP. |
