What is ICH Guideline?
ICH (Full form = International Conference on Harmonisation) is a committee that provides the pharmaceutical stability guidelines for industries. ICH
stability guidelines for stability conditions and testing are followed throughout the world for product quality.
Following is the list of ICH guidelines for stability testing:
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 ICH guidelines for impurities in active pharmaceutical ingredients.
Q3B(R2) – Impurities in New Drug Products: This part of ICH stability guidelines for stability testing 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 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
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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 – ICH Q7 guidelines have 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.
Q13 – Continuous Manufacturing of Drug Substances and Drug Products: Provide guidance to industry and regulatory agencies regarding
regulatory expectations on the development, implementation, and assessment of CM technologies used in the manufacture of drug substances and
drug products.
Q14 – Analytical Procedure Development
