STANDARDISATION OF HERBAL EXTRACTS ZHARI ISMAIL PhD PUSAT - - PowerPoint PPT Presentation

standardisation of
SMART_READER_LITE
LIVE PREVIEW

STANDARDISATION OF HERBAL EXTRACTS ZHARI ISMAIL PhD PUSAT - - PowerPoint PPT Presentation

STANDARDISATION OF HERBAL EXTRACTS ZHARI ISMAIL PhD PUSAT PENGAJIAN SAINS FARMASI UNIVERSITI SAINS MALAYSIA National Regulatory Conference 2013, 7-9 May, Kuala Lumpur CONTENTS INTRODUCTION WHAT & WHY OF STANDARDISATION HOW TO


slide-1
SLIDE 1

ZHARI ISMAIL PhD

PUSAT PENGAJIAN SAINS FARMASI UNIVERSITI SAINS MALAYSIA

National Regulatory Conference 2013, 7-9 May, Kuala Lumpur

STANDARDISATION OF HERBAL EXTRACTS

slide-2
SLIDE 2
  • INTRODUCTION
  • WHAT & WHY OF STANDARDISATION
  • HOW TO STANDARDISED
  • WHEN, WHERE & WHO
  • ISSUES & PROBLEMS
  • CONCLUSION

CONTENTS

National Regulatory Conference 2013, 7-9 May, KL

slide-3
SLIDE 3

Introduction

  • Label accuracy of herbal products
  • Authenticity
  • Quality
  • Safety
  • Efficacy issues
  • Quality of life or wellness products

8 May 2013 3 National Regulatory Conference 2013, 7-9 May, KL

slide-4
SLIDE 4

What & why standardised

  • Consistently consistent product
  • Reproducibility
  • Guaranteed potent/active
  • Value added
  • Prerequisite for preclinical & clinical studies

8 May 2013 4 National Regulatory Conference 2013, 7-9 May, KL

slide-5
SLIDE 5

How to standardise

  • Chemically
  • Biologically
  • Physicochemical parameters
  • Spectroscopically
  • Chromatographically
  • Metabolomics
  • Chemometrics

8 May 2013 5 National Regulatory Conference 2013, 7-9 May, KL

slide-6
SLIDE 6

When, where and who

  • From seeds to shelve
  • GACP, GLP, GMP
  • Trained technical personnel
  • Registered professionals

8 May 2013 6 National Regulatory Conference 2013, 7-9 May, KL

slide-7
SLIDE 7

Issues & problems

  • Standard materials
  • Collection of reference standards
  • Marker compounds
  • Official methods
  • Technical Monographs

8 May 2013 7 National Regulatory Conference 2013, 7-9 May, KL

slide-8
SLIDE 8

Conclusion

  • Garbage in garbage out
  • Must have rather than nice to have
  • Transformation of products
  • High value herbs
  • Fulfilling global needs

8 May 2013 8 National Regulatory Conference 2013, 7-9 May, KL

slide-9
SLIDE 9

Terima kasih