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Pregledni rad – Review Paper

HERBAL REMEDIES - QUALITY CONTROL REQUIREMENTS AND GOOD MANUFACTURING PRACTICE

By
Milica Mihailović
Milica Mihailović

Institute for Medicinal Plant Research „Dr Josif Pančić“, Belgrade, Serbia

Abstract

The use of medicinal plants is significant, especially in developing countries where traditional medicine is an integral part of the formal health care system, while in the developed countries in Europe and all over the World, developed the concept of a rational phytotherapy. Although herbal medicines are in use for centuries, standards and requirements of their control, from year to year are becoming stricter and on higher level. It is important to understand the issues of control and production of this type of drugs, ranging from specific raw materials to finished products. In this paper we report how have introduced regulations to control production of herbal medicines in order to induce improvement and development. It is important to note that the same approach to production and quality control should be applied to herbal medicines and traditional herbal remedies. The aim of this text is to emphasize the importance of herbal medicines in the world and in our country since they still represent an inexhaustible source of new scientific knowledge. Their importance for pharmacological research and drug development not only for the active herbal ingredients which are used as they are for therapeutic purposes, but also because they represent a starting material for the synthesis of drugs or as models for the production of new, pharmacologically active substances.

References

EMEA/ HMPC. (2006a). Guideline on Good Agricultural and Collection Practice (GACP) for Starting Materials of Herbal Origin.
EMEA/CPMP. (2006b). Guideline on specifications: Test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products.
EMEA/CPMP . (2006c). Note for guidance on quality of herbal medicinal products.
Kovačević, N. (2002). Osnovi farmakognoziije.
Kovačević, N. (2003). Biljne droge i status biljnih lekova u Jugoslaviji. 83–98.
Liang, Y. Z., Xie, P., & Chan, K. (2004). Quality control of herbal medicines. J. Chromatogr. B, 812, 53–70.
Niazi, K. S. (2007). Characterization of Phytomedicines in Handbook of Preformulation.
Pulok, M. K. (2002). Problems and prospects for good manufacturing practice for herbal drugs in Indian systems of medicine. Drug Inform. Journal, 635–644.
Službeni glasnik RS. (2008). Smernice Dobre proizvođačke prakse.
Službeni glasnik RS. (2010a). Pravilinik o uslovima u pogledu zdravstvene ispravnosti dijetetskih namirnica i dijetetskih suplemenata koji se mogu stavljati u promet.
Službeni glasnik RS. (2010b). Zakon o lekovima i medicinskim sredstvima.
W, C. D., H, K. J., Y, C. S., H, K. D., & Y, C. S. (2002). Regulation and quality. 581–586.
WHO. (2007a). guidelines on good manufacturing practices (GMP) for herbal medicines.
WHO. (2007b). Guidelines on good manufacturing practices (GMP): main principles for pharmaceutical products.
WHO . (2003). Guidelines on good agricultural and collection practices (GACP) for medicinal plants.

Citation

This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 

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