QUALITY REQUIREMENTS AND QUALITY STANDARDS FOR MEDICINAL, AROMATIC AND SPICE PLANTS

ISHS Acta Horticulturae 249: International Symposium on Heavy Metals and Pesticide Residues in Medicinal, Aromatic and Spice Plants

QUALITY REQUIREMENTS AND QUALITY STANDARDS FOR MEDICINAL, AROMATIC AND SPICE PLANTS

Author:

P. Dr. Heinz Schilcher

Abstract:
Quality requirements and quality standards are determined primarily in line with the purpose for which the plants, cultivated or gathered in the wild, are to be used. The requirements and standards may be laid down by legislation or by private agreement. The following possibilities exist:

The provisions of the pharmacopoeia currently valid in the various countries, with special emphasis on the legally prescribed measurement of residues and impurities (1,2,3) -
The provisions of older pharmacopoeiae if the drug concerned is no longer listed in the current one -
In the Federal Republic of Germany, for a number of drugs in addition to DAB 9 the provisions of the Deutscher Arzneimittel-Codex (DAC 79) (4) -
In the Federal Republic of Germany, for 91 drugs the legislative provisions of the so-called standard registrations (5) -
"Private" standards established on a contractual basis by pharmaceuticals companies, associations, cooperatives, etc. -
The requirements and standards of the Codex Alimentarius -
The quality standards demanded or sought by the spice and aromatics industry (6).

The pharmacopoeia requirements - the paper presents a detailed report on the standards of the European Pharmacopoeia and DAB 9 - are largely very similar in the various national pharmacopoeia, and in all countries they cannot always be strictly adhered to. More intensive cooperation is urgently needed between the national pharmacopoeia commissions and the drug manufacturers, as too is international coordination.

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