Drugs

International Council on Harmonisation-Quality

Below is a sortable list of the International Council on Harmonisation - Quality Guidance Documents. You can sort alphabetically by: Category/Subject Area; Guidance Title; Guidance Type (Draft or Final) and also sort by the Date the Guidance was issued.

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

CategoryTitleTypeDate
International Council on Harmonisation - Quality Q1A(R2) Stability Testing of New Drug Substances and Products (PDF - 58KB) Final Guidance 11/01/03
International Council on Harmonisation - Quality Q1B Photostability Testing of New Drug Substances and Products (PDF - 339KB) Final Guidance 11/01/96
International Council on Harmonisation - Quality Q1C Stability Testing for New Dosage Forms (PDF - 101KB) Final Guidance 05/09/97
International Council on Harmonisation - Quality Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products (PDF - 31KB) Final Guidance 01/01/03
International Council on Harmonisation - Quality Q1E Evaluation of Stability Data (PDF - 221KB) Final Guidance 06/01/04
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 03/01/95
International Council on Harmonisation - Quality Q2B Validation of Analytical Procedures: Methodology (PDF - 132KB) Final Guidance 05/19/97
International Council on Harmonisation - Quality Q3A(R) Impurities in New Drug Substances (PDF - 55KB) Final Guidance 06/06/08
International Council on Harmonisation - Quality Q3B(R) Impurities in New Drug Products (Revision 2) (PDF - 171KB) Final Guidance 08/04/06
International Council on Harmonisation - Quality Q3C Impurities: Residual Solvents (PDF - 41KB) Final Guidance 12/24/97
International Council on Harmonisation - Quality Q3C Tables and List  (PDF - 182KB) Final Guidance 02/22/12
International Council on Harmonisation - Quality Q3C Impurities: Residual Solvents: Maintenance Procedures for the Guidance for Industry Q3C Procedures/Recommendations 10/15/15
International Council on Harmonisation - Quality Q3C Appendix 4  (PDF - 120KB) Draft Guidance 03/18/98
International Council on Harmonisation - Quality Q3C Appendix 5 (PDF - 216KB) Draft Guidance 03/18/98
International Council on Harmonisation - Quality Q3C Appendix 6 (PDF - 128KB) Draft Guidance 03/18/98
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 02/20/07
International Council on Harmonisation - Quality Q4B: Annex I: Residue on Ignition/Sulphated Ash General Chapter  (PDF - 36KB) Final Guidance 02/20/07
International Council on Harmonisation - Quality Q4B: Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter (PDF - 79KB) Final Guidance 01/08/09
International Council on Harmonisation - Quality Q4B: Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter  (PDF - 1.2MB) Final Guidance 01/08/09
International Council on Harmonisation - Quality Q4B: Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter (PDF - 81KB) Final Guidance 04/07/09
International Council on Harmonisation - Quality Q4B: Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter (PDF - 82KB) Final Guidance 04/07/09
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 - 75KB) Final Guidance 04/07/09
International Council on Harmonisation - Quality Q4B: Annex 5: Disintegration Test General Chapter (PDF - 85KB) Final Guidance 12/22/09
International Council on Harmonisation - Quality Q4B: Annex 6: Uniformity of Dosage Units General Chapter  (PDF - 53KB) Final Guidance 06/13/14
International Council on Harmonisation - Quality Q4B: Annex 7(R2): Dissolution Test General Chapter (PDF - 102KB) Final Guidance 06/23/11
International Council on Harmonisation - Quality Q4B: Annex 8: Sterility Test General Chapter (PDF - 84KB) Final Guidance 12/22/09
International Council on Harmonisation - Quality Q4B: Annex 9: Tablet Friability General Chapter (PDF - 84KB) Final Guidance 04/02/10
International Council on Harmonisation - Quality Q4B: Annex 10: Polyacrylamide Gel Electrophoresis General Chapter (PDF - 84KB) Final Guidance 04/09/10
International Council on Harmonisation - Quality Q4B Annex 11: Capillary Electrophoresis General Chapter (PDF - 93KB) Final Guidance 09/02/10
International Council on Harmonisation - Quality Q4B Annex 12: Analytical Sieving General Chapter (PDF - 87KB) Final Guidance 09/01/10
International Council on Harmonisation - Quality Q4B Annex 13: Bulk Density and Tapped Density of Powders General Chapter (PDF - 94KB) Final Guidance 05/24/13
International Council on Harmonisation; Quality Q4B Annex 14: Bacterial Endotoxins Test General Chapter (PDF - 96KB) Final Guidance 10/15/13
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 09/01/98
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 02/01/96
International Council on Harmonisation - Quality Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products (PDF - 70KB) Final Guidance 07/01/96
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 09/21/98
International Council on Harmonisation - Quality Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process (PDF - 58KB) Final Guidance 06/01/05
International Council on Harmonisation - Quality Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances Final Guidance 12/29/00
International Council on Harmonisation - Quality Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (PDF - 54KB) Final Guidance 08/01/99
International Council on Harmonisation - Quality 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) Final Guidance 08/01/01
International Council on Harmonisation - Quality Q8(R2) Pharmaceutical Development (PDF - 402KB) Final Guidance 11/20/09
International Council on Harmonisation - Quality Q9 Quality Risk Management (PDF - 113KB) Final Guidance 06/01/06
International Council on Harmonisation - Quality Q10 Pharmaceutical Quality System (PDF - 274KB) Final Guidance 04/07/09
International Council on Harmonisation - Quality Q8, Q9, and Q10 Questions and Answers (PDF - 185KB) Final Guidance 11/01/11
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 07/25/12
International Council on Harmonisation - Quality Q11 Development and Manufacture of Drug Substances (PDF - 708KB) Final Guidance 11/19/12
International Council on Harmonisation - Quality Q3D Elemental Impurities (PDF - 685KB) Final Guidance 09/09/15

Page Last Updated: 03/04/2016
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