Singh, Sonia
Process validation: needed approach for herbal drugs - Vol.53(8-9), Aug-Sep - Mumbai Indian Journal of Pharmaceutical Science 2021 - 26-30p.
Worldwide, approximately the majority of individuals (around 80%) rely on the utilisation of herbs for their primary healthcare needs.
Herbal drugs have earned considerable acceptability in the market as in the form of products, such as LIV-52, Triphala, etc. The gaining
popularity of such systems of medicine is due to less or negligible toxicity, even in prolonged use of herbal medicines. Therefore, now-
a-days the need for herbs has increased tremendously. This demand would lead to the shortage of raw materials for manufacturing or
formulation purposes and would ultimately lead to unauthenticated use of adulteration/ substitution. Thus, there is a need to set up
quality assurance parameters for proper validation of raw herbal drug(s) and even herbal formulations. Standardization is an essential
validation required for the proper establishment of organoleptic, microscopic standards, physical, chemical parameters and biological
assay essential for maintaining the quality, purity of herbal products. Therefore, new approaches have been developed for the process
validation of herbs including DNA barcoding, wooden-tip electrospray ionization and pharmacovigilance.
PHARMACEUTICS
Process validation: needed approach for herbal drugs - Vol.53(8-9), Aug-Sep - Mumbai Indian Journal of Pharmaceutical Science 2021 - 26-30p.
Worldwide, approximately the majority of individuals (around 80%) rely on the utilisation of herbs for their primary healthcare needs.
Herbal drugs have earned considerable acceptability in the market as in the form of products, such as LIV-52, Triphala, etc. The gaining
popularity of such systems of medicine is due to less or negligible toxicity, even in prolonged use of herbal medicines. Therefore, now-
a-days the need for herbs has increased tremendously. This demand would lead to the shortage of raw materials for manufacturing or
formulation purposes and would ultimately lead to unauthenticated use of adulteration/ substitution. Thus, there is a need to set up
quality assurance parameters for proper validation of raw herbal drug(s) and even herbal formulations. Standardization is an essential
validation required for the proper establishment of organoleptic, microscopic standards, physical, chemical parameters and biological
assay essential for maintaining the quality, purity of herbal products. Therefore, new approaches have been developed for the process
validation of herbs including DNA barcoding, wooden-tip electrospray ionization and pharmacovigilance.
PHARMACEUTICS