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S.Selvadurai.,M.Pharm.,MBA.,
Associate Professor
Department of Pharmacognosy
QUALITY REFERES TO:
ICH is the
“International Council for
Harmonization of Technical
Requirement for Pharmaceuticals
for Human Use”
ROLE OF ICH Guidelines
ICH is non-Profit association started in 1990 to co-ordinate
regulatory bodies and Pharmaceutical Industry.
ICH brings together experts from all fields to discuss
scientific & technical aspects of drug registration
The mission behind ICH is to achieve greater harmonisation
worldwide for Safe, Effective & High quality medicines.
ICH brings uniformity throughout world & avoid confusion.
ICH does not give separate guidelines only for herbal drugs as such
Drug Development, Formulation, Analytical method development, Stability
testing, Clinical trials & other activity related to herbal dtugs are done
according to ICH guidelines.
It was established in 1948 for
international health matters & Public
Health
WHO has wide area & several functions
including provision of reliable
information & advice in the field of
Human health.
WHO deals with Diseases as well as
give guidelines for traditional & herbal
medicine.
According to WHO Survey, more than
60% of World population use one or
either form of traditional medicines.
• Gives a general IntroductionSection-I
• Discuss good agriculture practices for
medical plantsSection-II
Section – III
• Describes common technical aspects of good
agricultural practices for medical plants &
good collection practices for medicinal plants.
Section - IV
Section V
Discuss good collection practices for
medicinal plants
Considers other relevant issues
QUALITY EVALUATION OF
HERBAL DRUGS
Standardization & Quality Evaluation of Herbal drugs
10. WHO & ICH guidelines

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10. WHO & ICH guidelines

  • 2.
  • 3.
  • 5.
  • 6. ICH is the “International Council for Harmonization of Technical Requirement for Pharmaceuticals for Human Use”
  • 7. ROLE OF ICH Guidelines
  • 8. ICH is non-Profit association started in 1990 to co-ordinate regulatory bodies and Pharmaceutical Industry. ICH brings together experts from all fields to discuss scientific & technical aspects of drug registration The mission behind ICH is to achieve greater harmonisation worldwide for Safe, Effective & High quality medicines. ICH brings uniformity throughout world & avoid confusion. ICH does not give separate guidelines only for herbal drugs as such Drug Development, Formulation, Analytical method development, Stability testing, Clinical trials & other activity related to herbal dtugs are done according to ICH guidelines.
  • 9.
  • 10. It was established in 1948 for international health matters & Public Health WHO has wide area & several functions including provision of reliable information & advice in the field of Human health. WHO deals with Diseases as well as give guidelines for traditional & herbal medicine. According to WHO Survey, more than 60% of World population use one or either form of traditional medicines.
  • 11. • Gives a general IntroductionSection-I • Discuss good agriculture practices for medical plantsSection-II Section – III • Describes common technical aspects of good agricultural practices for medical plants & good collection practices for medicinal plants. Section - IV Section V Discuss good collection practices for medicinal plants Considers other relevant issues
  • 12. QUALITY EVALUATION OF HERBAL DRUGS Standardization & Quality Evaluation of Herbal drugs