A proposal for a quality system for herbal products

Today, there is an increasing worldwide demand for botanicals. Developing countries heavily rely on plant-derived medicines for their primary healthcare. One reason amongst many is the relatively inexpensive process economics and the lack of stringent product governance associated with the exploitat...

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Main Authors: Pan, S., Neeraj, A., Srivastava, K., Kishore, P., Danquah, Michael, Sarethy, I.
Format: Journal Article
Published: John Wiley & Sons Inc 2013
Online Access:http://hdl.handle.net/20.500.11937/39717
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author Pan, S.
Neeraj, A.
Srivastava, K.
Kishore, P.
Danquah, Michael
Sarethy, I.
author_facet Pan, S.
Neeraj, A.
Srivastava, K.
Kishore, P.
Danquah, Michael
Sarethy, I.
author_sort Pan, S.
building Curtin Institutional Repository
collection Online Access
description Today, there is an increasing worldwide demand for botanicals. Developing countries heavily rely on plant-derived medicines for their primary healthcare. One reason amongst many is the relatively inexpensive process economics and the lack of stringent product governance associated with the exploitation of traditional plant medicines compared with modern medicine. Developed countries impose stringent good manufacturing practices and quality control measures on drug products derived from any manufacturing process, regardless of the primary raw material. However, several factors hamper the full-scale application of traditional plant medicines: lack of implementation of effective quality assurance in the manufacturing process; lack of traceability in the supply chain and associated value additions; and inefficient identification of molecular species that affect the therapeutic efficacy of the final product. There lacks an assessable, causative, and prognostic relationship between the raw materials, the manufacturing process and the final product quality. This article suggests some solutions that may be adopted by the phytodrug industry to widen its global reach and retain its credibility. Primarily among them is the implementation of hazards analysis and critical control point in the manufacturing process and employment of process analytical technology for ensuring minimal deviation from the manufacturing process of phytotherapeutics.
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spelling curtin-20.500.11937-397172017-09-13T14:30:05Z A proposal for a quality system for herbal products Pan, S. Neeraj, A. Srivastava, K. Kishore, P. Danquah, Michael Sarethy, I. Today, there is an increasing worldwide demand for botanicals. Developing countries heavily rely on plant-derived medicines for their primary healthcare. One reason amongst many is the relatively inexpensive process economics and the lack of stringent product governance associated with the exploitation of traditional plant medicines compared with modern medicine. Developed countries impose stringent good manufacturing practices and quality control measures on drug products derived from any manufacturing process, regardless of the primary raw material. However, several factors hamper the full-scale application of traditional plant medicines: lack of implementation of effective quality assurance in the manufacturing process; lack of traceability in the supply chain and associated value additions; and inefficient identification of molecular species that affect the therapeutic efficacy of the final product. There lacks an assessable, causative, and prognostic relationship between the raw materials, the manufacturing process and the final product quality. This article suggests some solutions that may be adopted by the phytodrug industry to widen its global reach and retain its credibility. Primarily among them is the implementation of hazards analysis and critical control point in the manufacturing process and employment of process analytical technology for ensuring minimal deviation from the manufacturing process of phytotherapeutics. 2013 Journal Article http://hdl.handle.net/20.500.11937/39717 10.1002/jps.23732 John Wiley & Sons Inc restricted
spellingShingle Pan, S.
Neeraj, A.
Srivastava, K.
Kishore, P.
Danquah, Michael
Sarethy, I.
A proposal for a quality system for herbal products
title A proposal for a quality system for herbal products
title_full A proposal for a quality system for herbal products
title_fullStr A proposal for a quality system for herbal products
title_full_unstemmed A proposal for a quality system for herbal products
title_short A proposal for a quality system for herbal products
title_sort proposal for a quality system for herbal products
url http://hdl.handle.net/20.500.11937/39717