The third revision considers new and revised guidelines, questions and answers and the Ph. Eur. revised general monograph “Herbal Drug Extracts”. It covers general quality aspects of herbal medicinal products (HMPs) for human and veterinary use as well as traditional herbal medicinal products (THMPs) for human use and newly includes further quality data requirements. It is adjusted and aligned
It comes along with the new requirements
If a monograph for a herbal substance exists in the European Pharmacopoeia (Ph. Eur.) or another Pharmacopoeia, the herbal substance must be in accordance with this monograph.
In general, herbal substances must be tested, unless otherwise justified, for microbiological quality, mycotoxins (aflatoxins, ochratoxin A), residues of pesticides and fumigation agents, heavy metals and likely contaminants (including heavy metals not mentioned in the monograph “Herbal drugs” of the Ph. Eur. and contaminants present in the specific environment), foreign matter and adulterants, etc.
Descriptions of the analytical procedures must be submitted, together with the limits applied.
The control tests on the finished product should allow the qualitative and quantitative determination of the active substance(s) as well as the determination of characteristic properties of the dosage form and the entire finished product including packaging characteristics. Chromatographic fingerprinting should be used, based on appropriate chromatographic methods. A specification should be provided including tests for all relevant parameters.
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