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International Council for Harmonisation-Quality

International Conference on Harmonisation has changed its name to International Council for Harmonisation

Category Title Type Date
International Council on Harmonisation - Quality Q1A(R2) Stability Testing of New Drug Substances and Products (PDF - 58KB) Final Guidance 11/1/2003
International Council on Harmonisation - Quality Q1B Photostability Testing of New Drug Substances and Products (PDF - 339KB) Final Guidance 11/1/1996
International Council on Harmonisation - Quality Q1C Stability Testing for New Dosage Forms (PDF - 101KB) Final Guidance 5/9/1997
International Council on Harmonisation - Quality Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products (PDF - 31KB) Final Guidance 1/1/2003
International Council on Harmonisation - Quality Q1E Evaluation of Stability Data (PDF - 221KB) Final Guidance 6/1/2004
International Council on Harmonisation - Quality 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.]    
International Council on Harmonisation - Quality Q2A Text on Validation of Analytical Procedures  (PDF - 25KB) Final Guidance 3/1/1995
International Council on Harmonisation - Quality Q2B Validation of Analytical Procedures: Methodology (PDF - 132KB) Final Guidance 5/19/1997
International Council on Harmonisation - Quality Q3A(R) Impurities in New Drug Substances (PDF - 55KB) Final Guidance 6/6/2008
International Council on Harmonisation - Quality Q3B(R) Impurities in New Drug Products (Revision 2) (PDF - 171KB) Final Guidance 8/4/2006
International Council on Harmonisation - Quality Q3C Impurities: Residual Solvents (PDF - 41KB) Final Guidance 12/24/1997
International Council on Harmonisation - Quality Q3C Tables and List  (PDF - 276KB) Final Guidance 7/24/2017
International Council on Harmonisation - Quality Q3C Impurities: Residual Solvents: Maintenance Procedures for the Guidance for Industry Q3C Procedures/Recommendations 7/24/2017
International Council on Harmonisation - Quality Q3C Appendix 4  (PDF - 120KB) Draft Guidance 3/18/1998
International Council on Harmonisation - Quality Q3C Appendix 5 (PDF - 216KB) Draft Guidance 3/18/1998
International Council on Harmonisation - Quality Q3C Appendix 6 (PDF - 128KB) Draft Guidance 3/18/1998
International Council on Harmonisation - Quality Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions (PDF - 55KB) Final Guidance 2/20/2007
International Council on Harmonisation - Quality Q4B: Annex I: Residue on Ignition/Sulphated Ash General Chapter  (PDF - 58KB) Final Guidance 9/18/2017
International Council on Harmonisation - Quality Q4B: Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter (PDF - 69KB) Final Guidance 9/18/2017
International Council on Harmonisation - Quality Q4B: Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter  (PDF - 993KB) Final Guidance 9/18/2017
International Council on Harmonisation - Quality Q4B: Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter (PDF - 69KB) Final Guidance 9/18/2017
International Council on Harmonisation - Quality Q4B: Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter (PDF - 69KB) Final Guidance 9/18/2017
International Council on Harmonisation - Quality Q4B: Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter (PDF - 57KB) Final Guidance 9/18/2017
International Council on Harmonisation - Quality Q4B: Annex 5: Disintegration Test General Chapter (PDF - 69KB) Final Guidance 9/18/2017
International Council on Harmonisation - Quality Q4B: Annex 6: Uniformity of Dosage Units General Chapter (PDF - 53KB) Final Guidance 6/13/2014
International Council on Harmonisation - Quality Q4B: Annex 7(R2): Dissolution Test General Chapter (PDF - 102KB) Final Guidance 6/23/2011
International Council on Harmonisation - Quality Q4B: Annex 8: Sterility Test General Chapter (PDF - 68KB) Final Guidance 9/18/2017
International Council on Harmonisation - Quality Q4B: Annex 9: Tablet Friability General Chapter (PDF - 68KB) Final Guidance 9/18/2017
International Council on Harmonisation - Quality Q4B: Annex 10: Polyacrylamide Gel Electrophoresis General Chapter (PDF - 57KB) Final Guidance 9/18/2017
International Council on Harmonisation - Quality Q4B Annex 11: Capillary Electrophoresis General Chapter (PDF - 93KB) Final Guidance 9/2/2010
International Council on Harmonisation - Quality Q4B Annex 12: Analytical Sieving General Chapter (PDF - 87KB) Final Guidance 9/1/2010
International Council on Harmonisation - Quality Q4B Annex 13: Bulk Density and Tapped Density of Powders General Chapter (PDF - 94KB) Final Guidance 5/24/2013
International Council on Harmonisation; Quality Q4B Annex 14: Bacterial Endotoxins Test General Chapter (PDF - 96KB) Final Guidance 10/15/2013
International Council on Harmonisation - Quality Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin (PDF - 71KB) Final Guidance 9/1/1998
International Council on Harmonisation - Quality Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products (PDF - 109KB) Final Guidance 2/1/1996
International Council on Harmonisation - Quality Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products (PDF - 70KB) Final Guidance 7/1/1996
International Council on Harmonisation - Quality Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability (PDF - 52KB) Final Guidance 9/21/1998
International Council on Harmonisation - Quality Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process (PDF - 58KB) Final Guidance 6/1/2005
International Council on Harmonisation - Quality Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances Final Guidance 12/29/2000
International Council on Harmonisation - Quality Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (PDF - 54KB) Final Guidance 8/1/1999
International Council on Harmonisation - Quality Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Guidance for Industry (PDF - 253KB) Final Guidance 9/30/2016
International Council on Harmonisation - Quality Q8(R2) Pharmaceutical Development (PDF - 402KB) Final Guidance 11/20/2009
International Council on Harmonisation - Quality Q9 Quality Risk Management (PDF - 113KB) Final Guidance 6/1/2006
International Council on Harmonisation - Quality Q10 Pharmaceutical Quality System (PDF - 274KB) Final Guidance 4/7/2009
International Council on Harmonisation - Quality Q8, Q9, and Q10 Questions and Answers (PDF - 185KB) Final Guidance 11/1/2011
International Council on Harmonisation - Quality Q8, Q9, & Q10 Questions and Answers -- Appendix: Q&As from Training Sessions (Q8, Q9, & Q10 Points to Consider) Final Guidance 7/25/2012
International Council on Harmonisation - Quality Q11 Development and Manufacture of Drug Substances (PDF - 708KB) Final Guidance 11/19/2012
International Council on Harmonisation - Quality Q3D Elemental Impurities (PDF - 685KB) Final Guidance 9/9/2015
International Council on Harmonisation - Quality Q11 Development and Manufacture of Drug Substances--Questions and Answers (Chemical Entities and Biotechnological/Biological Entities) (PDF - 843KB) Final Guidance 2/23/2018
International Council on Harmonisation - Quality Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Questions and Answers Guidance for Industry (PDF - 218KB) Final Guidance 4/19/2018
International Council for Harmonisation-Quality Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Core Guideline Guidance for Industry (PDF - 451KB) Draft Guidance 5/30/2018
International Council for Harmonisation-Quality Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex (PDF - 223KB) Draft Guidance 5/30/2018
International Council on Harmonisation - Quality Q3D(R1) ELEMENTAL IMPURITIES (PDF - 177KB) Draft Guidance 7/13/2018