6.1. ICH and Who guidelines in quality control of crude drugs (2).pptx

good

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

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 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.)

9. 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

10. 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

11. 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

12. 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

13. QUALITY CONTROL METHODS FOR HERBAL DRUGS Powder fineness and sieve size Determination of foreign matter Macroscopic and microscopic examination Thin-layer chromatography Determination of ash Determinati o n matter Determination volatile matter of extractable of w a ter and Determination of volatile oils Determination of bitterness value Dete r mi n ati o n o f ha e m ol y tic activity Determination of tannins Determination of swelling index Determination of foaming index Determination of pesticide residues Determination of arsenic and heavy metals Determination of microorganisms Radioactive contamination 9