Revised ICH (International Conference on Hormonisation) Quality Guidelines in pharmaceuticals are given below:
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)
