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,
QSEM
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 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 | Pharmacopeial Harmonisation |
| Q4B | Evaluation 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 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 : Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products |
| Q5C | Stability testing of biotechnological/biological products |
| 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 |
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