It is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.

1. Quality Control & Standardization Of
Herbals
ICH Guideline For Quality Control Of Herbal Drugs
By
Kaushal Kumar

2. Tabel Of Contents
01 02 03 04
Introduction Objective Organization Guidelines

3. The International Council for Harmonization of Technical
Requirements for Pharmaceuticals for Human Use. (ICH)
was established in 1990.
It is unique in bringing together the regulatory authorities and
pharmaceutical industry to discuss scientific and technical
aspects of pharmaceuticals and develop ICH guidelines.
ICH's mission is to achieve greater harmonization worldwide to
ensure that safe, effective and high-quality medicines are
developed, and registered and maintained in the most resource-
efficient manner.
Introduction

4. Objective
 Harmonization of technical requirements
 Ensure safety, efficacy and quality of new drugs
 Prevent duplication of clinical trials in humans
 Minimize the use of animal testing without compromising safety and effectiveness
 More efficient use of resource
 Reducing testing duplication

5. Initiation Of ICH
 1980 – European Community
 1989 – WHO conference on Drug Regulatory Authorities, Paris
 1990 – Birth of ICH, Brussels
► Europe
► Japan
► US
Topic for harmonization divided into three types
► Safety
► Efficacy
► Quality

6. Organisation Of ICH
Steering Committee
Global Cooperation Group
Me DRA Management
Board
Secretariat Coordinators
ICH Working Groups
Q S E M

7. ICH Member
ICH Member
 European Commission-European Union (EU)
 European Federation of Pharmaceutical Industries and Associations (EFPIA)
 Ministry of Health, Labor and Welfare, Japan (MHLW)
 Japan Pharmaceutical Manufacturers Association (JPMA)
 US Food and Drug Administration (FDA)
 Pharmaceutical Research and Manufacturers of America (PhRMA)
Non- ICH Member (Not consider in the decision making process)
 WHO (World Health Organization)
 IFPMA (International Federation of Pharmaceutical Manufacturers and Associations)
 Canada Health

8. ICH Structure
Region Regulatory Body
Research Based
Industry
Japan MHLW JPMA
Europe EU EFPIA
US FDA PhRMA

9. ICH
Q: Quality Guidelines It is related to chemical and Pharmaceutical quality
Assurance (Stability Testing, Impurity Testing, etc.)
S: Safety Guidelines It is related to in vitro and in vivo pre-clinical studies
(Carcinogenicity Testing, Genotoxicity Testing, etc.)
E: Efficacy Guidelines It is related to clinical studies in a human subject
(Dose Response Studies, Good Clinical Practices, etc.).
M: Multidisciplinary Guidelines It includes cross-cutting topics which do not fit
uniquely into one of the above categories (MedDRA, ESTRI, M3, CTD, M5, etc.)

10. Quality Guidelines
Q1A - Q1F Stability Testing
Q2 Analytical Validation
Q3A – Q3D Impurities
Q4 Pharmacopeias
Q5A – Q5E Quality of Biotechnology Products
Q6A Specifications (Test Procedures & Acceptance Criteria)
Q7 GMP (Good Manufacturing Practice)
Q8 Pharmaceutical Development
Q9 Quality Risk Management
Q10 Pharmaceutical Quality System
Q11 Development & Manufacturing Of Drug Substances
Q12 Life cycle Managements
Q13 Continuous manufacturing of Drug substances & Drug Products
Q14 Analytical Procedure Development

11. Safety Guidelines
Guideline No. Guideline Name
S1 Carcinogenicity
S2 Genotoxicity Studies
S3 Toxicokinetic & Pharmacokinetics
S4 Toxicity Testing
S5 Reproductive Toxicology
S6 Biotechnological Products
S7 Pharmacology Studies
S8 Immunotoxicology Studies
S9 Non-Clinical Evaluation for Anti-cancer Drugs
S10 Photo Safety Evaluation
S11 Non-Clinical Paediatric Safety

12. Multidisciplinary
M1 MedDRA Terminology
M2 Electronic Standards
M3 Non-Clinical Safety Studies
M4 Common Technical Document
M5 Data Element & Standards For Drug Dictionaries
M6 Gene Therapy
M7 Mutagenic Impurities
M8 Electronic Common Technical Document (eCTD)
M9 Biopharmaceutics Classification System
M10 Bioanalytical Method Validation

13. Efficacy Guidelines
E1 - Clinical Safety For Drugs Used In Long Term Treatment
E2(A-F) - Pharmacovigilance
E3 - Clinical Study Reports
E4 - Dose-response Studies
E5 - Ethnic Factors
E6 - Good Clinical Practice
E7 - Clinical Trail in Geriatric Population
E8 - General Considerations For Clinical Trails
E9 - Statistical Principals For Clinical Trails
E10 - Choice Of Control Group In Clinical Trails
E11 - Clinical Trails In Paediatrics Population
E12 - Clinical Evaluation By Therapeutic Category
E14 - Clinical Evaluation Of QT
E15 - Definition In Pharmacogenetics / Pharmacogenomics
E17 - Multi-regional Clinical Trails
E18 - Genomic Sampling

14. THANKS!
Do you have any questions?
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