Overview of the ICH Guidelines

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an international organization that brings together regulatory authorities and the pharmaceutical industry to develop and promote harmonized guidelines and standards for the development, registration, and post-approval of pharmaceutical products.

Structure of the ICH

1. Management Committee: Comprised of regulatory authorities from each participating region (Europe, United States, Japan), as well as representatives from the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Japan Pharmaceutical Manufacturers Association (JPMA).

2. Steering Committee: Oversees the overall direction and strategy of the ICH.

3. Expert Working Groups (EWGs): Responsible for developing specific guidelines on various topics related to pharmaceutical development, such as quality, safety, efficacy, multidisciplinary topics, etc.

4. Implementation Working Groups (IWGs): Focuses on facilitating the implementation of ICH guidelines at a regional level.

5. Observers: Non-voting participants representing other regulatory authorities or organizations with an interest in pharmaceutical regulation.


The ICH was established in 1990 as a joint initiative between regulatory authorities and industry associations from Europe, United States, and Japan. Its primary goal was to reduce duplication in drug development requirements across regions and promote global harmonization. Since its inception, the ICH has developed numerous guidelines that have become widely accepted by regulatory authorities worldwide.

List of ICH Quality Guidelines

The ICH continues to evolve and update its guidelines to address emerging challenges in pharmaceutical development.

  • Q1A (R2) – Stability Testing of New Drug Substances and Products
  • Q1 B – Stability Testing : Photo Stability Testing of New Drug Substances and Products 
  • Q1C – Stability Testing for New Dosage Forms
  • Q1D – Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
  • Q1E – Evaluation of Stability Data
  • Q1F – Stability Data Package for Registration Application in Climatic Zones III and IV
  • Q2 (R1) – Validation of Analytical Procedures : Text and Methodology
  • Q3A (R2) – Impurities in New Drug Substances
  • Q3B (R2) – Impurities in New Drug Products
  • Q3C (R5) – Impurities : Guideline for Residual Solvents
  • Q3D – Impurities : Guideline for Elemental Impurities 
  • Q4 – Pharmacopoeias
  • Q4A – Pharmacopoeial Harmonisation
  • Q4B – Evaluation and Recommendation of Pharmacopoeial Text for use in the ICH Regions
  • Q4B Annex 1(R1) – Residue on Ignition /Sulphated Ash General Chapter
  • Q4B Annex 2(R1) – Test for Extractable Volume of Parenteral Preparation General Chapter 
  • Q4B – Annex 3(R1) – Test for Particulate Contamination : Sub-Visibal Particales General Chapter 
  • Q4B – Annex 4A(R1) – Microbiological Examination of Non-Sterile Products : Microbial Enumeration Tests General Chapter
  • Q4B – Annex 4B(R1) – Microbiological Examination of Non-Sterile Products : Test for Specified Micro-Organism General Chapter
  • Q4B – Annex 4C(R1) – Microbiological Examination of Non-Sterile Products : Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical use General Chapter
  • Q4B – Annex 5(R1) – Disintegration Test General Chapter
  • Q4B Annex 6 (R1) – Uniformity of Dosage Units General Chapter
  • Q4B Annex 7(R2) – Dissolution Test General Chapter
  • Q4B Annex 8(R1) – Stability Test General Chapter
  • Q4B Annex 9(R1) – Tablet Friability General Chapter
  • Q4B Annex 10(R1) – Polyacrylamide Gel Electrophoresis General Chapter
  • Q4B Annex 11 – Capillary Electrophoresis General Chapter
  • Q4B Annex 12 – Analytical Sieving General Chapter
  • Q4B Annex 13 – Bulk Density and Tapped Density of Powders General Chapter
  • Q4B Annex 14 – Bacterial Endotoxin Test General Chapter
  • Q5A(R1) – Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
  • Q5B – Quality of Biotechnology Products :
  • Q5C – Quality of Biotechnology Products :Quality of Biotechnological
  • Q5D – Derivation and Characterisation of Cell Substrates used for Production of Biotechnological/Biological Products
  • Q5E – Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process
  • Q6A – Specifications : Test Procedure and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
  • Q6B – Specifications : Test Procedure and Acceptance Criteria for Biotechnological/Biological
  • Q7 – Good Manufacturing Guide for Active Pharmaceutical Ingredients
  • Q8(R2) – Pharmaceutical Development
  • Q9 – Quality Risk Management
  • Q10 – Pharmaceutical Quality System
  • Q11 – Development and Manufacture of Drug Substances (Chemical Entities Biotechnological/Biological Entities)
  • Q12 – Life Cycle Management
  • Q13 – Analytical Procedure Development

For more information on the history and latest updates of the ICH, you can visit their official website: https://www.ich.org/

Post a Comment

أحدث أقدم