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List of Current ICH Quality Guidelines for Stability


Know all ICH guidelines for quality in pharmaceutical as Q1A, Q1B, Q1C, Q1D, Q1E, Q1F, Q2(R1), Q3A(R2), Q3B(R2), Q3C(R5), Q4, Q4A, Q4B, Q5A(R1), Q5B, Q5C, Q5D, Q5E, Q6A, Q6B, Q7, Q8(R2), Q9, Q10, and Q11

Q1A(R2) - Stability Testing of New Drug Substances and Products
Q1B - Stability Testing: Photostability Testing of New Drug Substances and Products
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
Q1E - Evaluation for Stability Data
Q1F - Stability Data Package for Registration Applications 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
Q4 - Pharmacopoeia
Q4A - Pharmacopoeial Harmonization
Q4B - 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: 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 Active Pharmaceutical Ingredients
Q8(R2) - Pharmaceutical Development
Q9 - Quality Risk Management
Q10 - Pharmaceutical Quality System
Q11 - Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)




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