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ICH (Full form = International Conference on Harmonisation) is a committee that provides the pharmaceutical guidelines for industries. ICH guidelines are followed throughout the world for product quality.
Following is the list of ICH guidelines:
Q1A(R2) - Stability Testing of New Drug Substances and Products: This guidance is for analysis of the product for its stability in different environmental conditions.
Q1B - Stability Testing: Photostability Testing of New Drug Substances and Products: This is also for stability studies of pharmaceutical products to test the effect of light on the product.
Q1C - Stability Testing for New Dosage Forms: Annex to the ICH Harmonised Tripartite Guideline on Stability Testing for New Drugs and Products
Q1D - Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products: This section of the guideline is for stability testing of product using Bracketing and Matrixing.
Q1E - Evaluation for Stability Data: This section has the method of evaluation of data found after analysis of drug products for stability testing.




Q1F - Stability Data Package for Registration Applications in Climatic Zones III and IV
Q2(R1) - Validation of Analytical Procedures:  Text and Methodology for analytical method validation for stability studies.
Q3A(R2) - Impurities In New Drug Substances:  It has information about impurities in active pharmaceutical ingredients.

Q3B(R2) - Impurities in New Drug Products: This part of guidelines has information of impurities in pharmaceutical finished products.
Q3C(R5) - Impurities: Guideline for determination of Residual Solvents in drug substances and drug products.
Q4 - Pharmacopoeia:
Q4A - Pharmacopoeial Harmonization: Details about the harmonization of pharmacopeias like USP, JP and EP.
Q4B - Guideline for Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
Q4B Annex 4A(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Microbial Enumerations Tests
Q4B Annex 4B(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Test for Specified Micro-Organisms
Q4B Annex 4C(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use
Q4B Annex 1(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Residue on Ignition/Sulphated Ash
Q4B Annex 2(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations
Q4B Annex 3(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles
Q4B Annex 5(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test
Q4B Annex 6(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of Dosage Units
Q4B Annex 7(R2) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Dissolution Test
Q4B Annex 8(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Sterility Test
Q4B Annex 9(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Tablet Friability
Q4B Annex 10(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Polyacrylamide Gel Electrophoresis




Q4B Annex 11 - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Capillary Electrophoresis
Q4B Annex 12 - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Analytical SievingQ4B Annex 10(R1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Polyacrylamide Gel Electrophoresis




Q4B Annex 11 - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Capillary Electrophoresis
Q4B Annex 12 - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Analytical Sieving
Q4B Annex 13 - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bulk Density and Tapped Density of Powders
Q4B Annex 14 - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bacterial Endotoxins Test
Q4B - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
Q5A(R1) - Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
Q5B - Quality of Biotechnological Products: Analysis of the Expression Construct in Cells used for Production of r-DNA Derived Protein Products
Q5C - Quality of Biotechnological Products: Guidelines for 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 Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
Q6B - Specifications: Test Procedures and Acceptance Criteria for Biotechnological/ Biological Products
Q7 - Good Manufacturing Practice Guide for APIs (Active Pharmaceutical Ingredients) during the manufacturing process
Q8(R2) - Pharmaceutical Development
Q9 - Quality Risk Management:  Recommendations for evaluation of risk involved in manufacturing processes.
Q10 - Pharmaceutical Quality System:  Recommendations to maintain the quality of the product.
Q11 - Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/ Biological Entities)
Q12 - Lifecycle Management: Guidelines on lifecycle management of pharmaceutical products.
Read details: ICH Quality Guidelines
By Bhupesh solanki from Bulandshahr

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