ICH- stands for International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Purpose: ICH purpose is to taking together the regulatory authorities and pharmaceutical industry to discuss scientific and technical facts of pharmaceuticals and develop ICH guidelines.

In the year 1989, Europe, United States and Japan began creating plans for harmonization. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was shaped in April 1990 at a summit in Brussels. 

Mainly based on QSEM which is,


Q stands for Quality Guidelines

S stands for Safety Guidelines

E stands for Efficacy Guidelines

M stands for Multidisciplinary

Quality Guidelines

Guideline No.Title
Q1A (R2)Stability Testing of New Drug Substances and Products
Q1 BStability Testing: Photo Stability Testing of New Drug Substances and Products
Q1CStability Testing for New Dosage Forms
Q1DBracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
Q1EEvaluation of Stability Data
Q1FStability 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
Q3DImpurities : Guideline for Elemental Impurities
Q4APharmacopeial Harmonisation
Q4BEvaluation and Recommendation of Pharmacopeial 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 11Capillary Electrophoresis General Chapter
Q4B Annex 12Analytical Sieving General Chapter
Q4B Annex 13Bulk Density and Tapped Density of Powders General Chapter
Q4B Annex 14Bacterial Endotoxin Test General Chapter
Q5A(R1)Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
Q5BQuality of Biotechnology Products : Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
Q5CStability testing of biotechnological/biological products
Q5DDerivation and Characterisation of Cell Substrates used for Production of Biotechnological/Biological Products
Q5EComparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process
Q6ASpecifications : Test Procedure and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
Q6BSpecifications : Test Procedure and Acceptance Criteria for Biotechnological/Biological
Q7Good Manufacturing Guide for Active Pharmaceutical Ingredients
Q8(R2)Pharmaceutical Development
Q9Quality Risk Management
Q10Pharmaceutical Quality System
Q11Development and Manufacture of Drug Substances (Chemical Entities Biotechnological/Biological Entities)
Q12Life Cycle Management
ICH-Quality Guidelines




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