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International Conference on Harmonisation - Quality
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Q1A(R2) Stability Testing of New Drug Substances and Products (PDF - 58KB)
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Final Guidance
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11/01/03
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International Conference on Harmonisation - Quality
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Q1B Photostability Testing of New Drug Substances and Products (PDF - 339KB)
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Final Guidance
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11/01/96
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International Conference on Harmonisation - Quality
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Q1C Stability Testing for New Dosage Forms (PDF - 101KB)
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Final Guidance
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05/09/97
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International Conference on Harmonisation - Quality
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Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products (PDF - 31KB)
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Final Guidance
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01/01/03
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International Conference on Harmonisation - Quality
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Q1E Evaluation of Stability Data (PDF - 221KB)
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Final Guidance
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06/01/04
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International Conference on Harmonisation - Quality
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Q2 (R1)Validation of Analytical Procedures: Text and Methodology [Note: In November 2005, the ICH incorporated Q2B on methodology with the parent guidance Q2A and retitled the combined document Q2(R1). The contents of Q2A and Q2B posted below were not revised.]
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International Conference on Harmonisation - Quality
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Q2A Text on Validation of Analytical Procedures (PDF - 25KB)
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Final Guidance
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03/01/95
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International Conference on Harmonisation - Quality
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Q2B Validation of Analytical Procedures: Methodology (PDF - 132KB)
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Final Guidance
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05/19/97
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International Conference on Harmonisation - Quality
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Q3A(R) Impurities in New Drug Substances (PDF - 55KB)
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Final Guidance
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06/06/08
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International Conference on Harmonisation - Quality
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Q3B(R) Impurities in New Drug Products (Revision 2) (PDF - 171KB)
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Final Guidance
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08/04/06
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International Conference on Harmonisation - Quality
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Q3C Impurities: Residual Solvents (PDF - 41KB)
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Final Guidance
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12/24/97
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International Conference on Harmonisation - Quality
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Q3C Tables and List (PDF - 182KB)
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Final Guidance
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02/22/12
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International Conference on Harmonisation - Quality
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Q3C Impurities: Residual Solvents: Maintenance Procedures for the Guidance for Industry Q3C
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Procedures/Recommendations
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02/11/02
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International Conference on Harmonisation - Quality
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Q3C Appendix 4 (PDF - 120KB)
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Draft Guidance
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03/18/98
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International Conference on Harmonisation - Quality
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Q3C Appendix 5 (PDF - 216KB)
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Draft Guidance
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03/18/98
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International Conference on Harmonisation - Quality
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Q3C Appendix 6 (PDF - 128KB)
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Draft Guidance
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03/18/98
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International Conference on Harmonisation - Quality
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Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions (PDF - 55KB)
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Final Guidance
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02/20/07
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International Conference on Harmonisation - Quality
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Q4B: Annex I: Residue on Ignition/Sulphated Ash General Chapter (PDF - 36KB)
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Final Guidance
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02/20/07
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International Conference on Harmonisation - Quality
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Q4B: Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter (PDF - 79KB)
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Final Guidance
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01/08/09
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International Conference on Harmonisation - Quality
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Q4B: Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter (PDF - 1.2MB)
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Final Guidance
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01/08/09
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International Conference on Harmonisation - Quality
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Q4B: Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter (PDF - 81KB)
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Final Guidance
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04/07/09
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International Conference on Harmonisation - Quality
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Q4B: Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter (PDF - 82KB)
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Final Guidance
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04/07/09
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International Conference on Harmonisation - Quality
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Q4B: Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter (PDF - 75KB)
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Final Guidance
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04/07/09
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International Conference on Harmonisation - Quality
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Q4B: Annex 5: Disintegration Test General Chapter (PDF - 85KB)
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Final Guidance
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12/22/09
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International Conference on Harmonisation - Quality
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Q4B: Annex 6: Uniformity of Dosage Units General Chapter (PDF - 87KB)
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Draft Guidance
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02/17/09
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International Conference on Harmonisation - Quality
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Q4B: Annex 7(R2): Dissolution Test General Chapter (PDF - 102KB)
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Final Guidance
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06/23/11
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International Conference on Harmonisation - Quality
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Q4B: Annex 8: Sterility Test General Chapter (PDF - 84KB)
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Final Guidance
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12/22/09
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International Conference on Harmonisation - Quality
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Q4B: Annex 9: Tablet Friability General Chapter (PDF - 84KB)
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Final Guidance
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04/02/10
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International Conference on Harmonisation - Quality
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Q4B: Annex 10: Polyacrylamide Gel Electrophoresis General Chapter (PDF - 84KB)
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Final Guidance
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04/09/10
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International Conference on Harmonisation - Quality
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Q4B Annex 11: Capillary Electrophoresis General Chapter (PDF - 93KB)
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Final Guidance
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09/02/10
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International Conference on Harmonisation - Quality
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Q4B Annex 12: Analytical Sieving General Chapter (PDF - 87KB)
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Final Guidance
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09/01/10
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International Conference on Harmonisation - Quality
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Q4B Annex 13: Bulk Density and Tapped Density of Powders General Chapter (PDF - 225KB)
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Draft Guidance
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07/13/10
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International Conference on Harmonisation; Quality
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Q4B Annex 14: Bacterial Endotoxins Test General Chapter (PDF - 351KB)
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Draft Guidance
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07/16/10
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International Conference on Harmonisation - Quality
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Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin (PDF - 71KB)
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Final Guidance
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09/01/98
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International Conference on Harmonisation - Quality
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Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products (PDF - 109KB)
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Final Guidance
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02/01/96
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International Conference on Harmonisation - Quality
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Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products (PDF - 70KB)
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Final Guidance
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07/01/96
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International Conference on Harmonisation - Quality
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Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability (PDF - 52KB)
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Final Guidance
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09/21/98
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International Conference on Harmonisation - Quality
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Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process (PDF - 58KB)
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Final Guidance
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06/01/05
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International Conference on Harmonisation - Quality
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Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
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Final Guidance
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12/29/00
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International Conference on Harmonisation - Quality
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Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (PDF - 54KB)
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Final Guidance
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08/01/99
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International Conference on Harmonisation - Quality
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Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients [Note: In November 2005, the ICH redesignated this guidance Q7. The guidance was not revised]. (PDF - 175KB)
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Final Guidance
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08/01/01
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International Conference on Harmonisation - Quality
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Q8(R2) Pharmaceutical Development (PDF - 402KB)
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Final Guidance
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11/20/09
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International Conference on Harmonisation - Quality
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Q9 Quality Risk Management (PDF - 113KB)
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Final Guidance
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06/01/06
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International Conference on Harmonisation - Quality
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Q10 Pharmaceutical Quality System (PDF - 274KB)
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Final Guidance
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04/07/09
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International Conference on Harmonisation - Quality
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Q8, Q9, and Q10 Questions and Answers (PDF - 185KB)
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Final Guidance
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11/01/11
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International Conference on Harmonisation - Quality
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Q8, Q9, & Q10 Questions and Answers -- Appendix: Q&As from Training Sessions (Q8, Q9, & Q10 Points to Consider)
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Final Guidance
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07/25/12
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International Conference on Harmonisation - Quality
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Q11 Development and Manufacture of Drug Substances (PDF - 758KB)
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Draft Guidance
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06/28/11
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