The document outlines the International Conference on Harmonisation (ICH), established in 1990 for the purpose of harmonizing global pharmaceutical regulations among the EU, Japan, and the USA. It emphasizes objectives such as ensuring the safety and efficacy of medicines, minimizing unnecessary clinical trials, and providing guidelines for quality, safety, and efficacy. Additionally, it details various stability testing guidelines and analytical validation processes critical for drug registration and quality assurance.

1. Presented by- Jaskiran Kaur
Guided by- Dr . Vijayakumar M.R.
Department of Pharmaceautical Sciences
Babasaheb Bhimrao Ambedkar University
Lucknow
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2. CONTENTS
1. Introduction
2. Mission
3. History
4. Objectives
5. Organisation of ICH
6. ICH Guidelines
7. Quality Guidelines –Q1
8. Quality Guidelines –Q2
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3. INTRODUCTION
• International Conference on Harmonisation (ICH) was created in 1990
• Agreement between the EU, Japan and the USA to harmonize different
regional requirements for registration of pharmaceutical drug products
• Unique because joint effort by regulators and associated pharmaceutical
industry trade associations
• ICH is the “International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for Human Use”.
• ICH is a joint initiative involving both regulators and research-based industry
representatives of the EU, Japan and the US in scientific and technical
discussions of the testing procedures required to asses and ensure the safety,
quality and efficacy of medicines.
• The ICH Secretariat is based in Geneva. The biennial meetings and
conferences of the ICH Steering Committee rotate between the EU, Japan,
and the USA.
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5. HISTORY
Need to harmonise?
Industry becoming global –
Duplicate test procedures
• Time consuming
• Expensive
Increasing R&D costs
Meeting public demand
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6. Initiation of ICH -
1980s: European Community
1989: WHO conference on Drug Regulatory Authorities, Paris
1990: Birth of ICH, Brussels
• Europe
• Japan
• US
 Topics for harmonisation divided into: Safety, Efficacy and Quality
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7. OBJECTIVES
• To increase international harmonization of technical requirements to
ensure that safe, effective and high quality medicines are developed.
• To harmonize technical requirements for registration or marketing
approval.
• To develop and register pharmaceuticals in the most efficient and
cost effective manner.
• To promote public health.
• To prevent unnecessary duplication of clinical trials on humans.
• To minimize the use of animal testing without compromising safety
and effectiveness of drug.
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8. Organisation of ICH
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12. • In Japan, the members are the Ministry of Health, Labour and Welfare
(MHLW), and the Japan Pharmaceutical Manufacturers Association
(JPMA).
• In Europe, the members are the European Union (EU), and the European
Federation of Pharmaceutical Industries and Associations (EFPIA).
• In the USA, the members are the Food and Drug Administration (FDA),
and the Pharmaceutical Research and Manufacturers of America
(PhRMA).
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14. ICH Guidelines
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ICH guidelines are classified into 4 types:
1. Quality guidelines
2. Safety guidelines
3. Efficacy guidelines
4. Multidisciplinary guidelines

15. • “Quality” Topics, i.e., those relating to chemical and pharmaceutical
Quality Assurance (Stability Testing, Impurity Testing, etc.)
• “Efficacy" Topics, i.e., those relating to clinical studies in human
subject (Dose Response Studies, Good Clinical Practices, etc.)
• “Safety” Topics, i.e., those relating to in vitro and in vivo pre-clinical
studies (Carcinogenicity Testing, Genotoxicity Testing, etc.)
• “Multidisciplinary” Topics, i.e., cross-cutting Topics which do not fit
uniquely into one of the above categories.
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17. List of Quality Guidelines
 Q1 - Stability
Q2 - Analytical validation
 Q3 - Impurities
 Q4 - Pharmacopoeia
 Q5 - Quality of biotechnological products
 Q6 - Specifications
 Q7 - GMP
 Q8 - Pharmaceutical development
 Q9 - QRM
 Q10 – Pharmaceutical Quality system
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18. Q1 Guidelines
• These are the stability guidelines.
• The purpose of stability testing is to provide evidence on how the
quality of a drug substance or drug product varies with time under
the influence of a variety of environmental factors such as
temperature, humidity, and light, and to establish a re-test period for
the drug substance or a shelf life for the drug product.
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19. Types of stabilities
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Chemical
Physical
Microbial
Therapeautical
Toxicological

20. List of Q1 Sub-guidelines
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21. Q1 A(R2): stability testing of new drug
substances and products
Test for APIs
• General
• Stress Testing
• Selection of Batches
• Container Closure System
• Specification
• Testing Frequency
• Storage Conditions
• Evaluation
• Statements/Labelling
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23. 1
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28. Stability testing of drug products
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32. Q1 B: Photostability testing of new drug
substances and products
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34. Q1 C :stability testing of new dosage
forms
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35. Q1 D :Bracketting and matrix design
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37. Q1 E :Evaluation of the stability data
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38. Q1 F: Stability Data Package for Registration
Applications in Climatic Zones III and IV
Describes harmonised global stability testing requirements in order to
facilitate access to medicines by reducing the number of different
storage conditions.
WHO conducted a survey amongst their member states to find
consensus on 30°C/65% RH as the long-term storage conditions for
hot-dry and hot-humid regions.
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40. Q2 Guidelines- Analytical validation
• Validation of Analytical Procedures: Text and Methodology
• The objective of validation of an analytical procedure is to
demonstrate that it is suitable for its intended purpose
• Gives validation parameters needed for a variety of analytical
methods.
• It also discusses the characteristics that must be considered
during the validation of the analytical procedures
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41. Types of Analytical Procedures to be validated are:
1. Identification tests;
2. Quantitative tests for impurities content;
3. Limit tests for the control of impurities;
4. Quantitative tests of the active moiety in samples of drug
substance or drug product or other selected components in the
drug product.
• Typical validation characteristics of analytical procedures Accuracy,
Precision(Repeatability, Intermediate Precision), Specificity, Detection
Limit, Quantitation Limit, Linearity, Range.
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Thank You!