List of ICH Quality Guidelines in Pharmaceuticals  

0
80416
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)
Q12 – Life Cycle Management