Drugs

International Conference on Harmonisation - Quality

Below is a sortable list of the International Conference 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.

CategoryTitleTypeDate
International Conference on Harmonisation - Quality Q1A(R2) Stability Testing of New Drug Substances and Products (PDF - 58KB) Final Guidance 11/01/03
International Conference on Harmonisation - Quality Q1B Photostability Testing of New Drug Substances and Products (PDF - 339KB) Final Guidance 11/01/96
International Conference on Harmonisation - Quality Q1C Stability Testing for New Dosage Forms (PDF - 101KB) Final Guidance 05/09/97
International Conference 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 Conference on Harmonisation - Quality Q1E Evaluation of Stability Data (PDF - 221KB) Final Guidance 06/01/04
International Conference 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 Conference on Harmonisation - Quality Q2A Text on Validation of Analytical Procedures  (PDF - 25KB) Final Guidance 03/01/95
International Conference on Harmonisation - Quality Q2B Validation of Analytical Procedures: Methodology (PDF - 132KB) Final Guidance 05/19/97
International Conference on Harmonisation - Quality Q3A(R) Impurities in New Drug Substances (PDF - 55KB) Final Guidance 06/06/08
International Conference on Harmonisation - Quality Q3B(R) Impurities in New Drug Products (Revision 2) (PDF - 171KB) Final Guidance 08/04/06
International Conference on Harmonisation - Quality Q3C Impurities: Residual Solvents (PDF - 41KB) Final Guidance 12/24/97
International Conference on Harmonisation - Quality Q3C Tables and List  (PDF - 182KB) Final Guidance 02/22/12
International Conference on Harmonisation - Quality Q3C Impurities: Residual Solvents: Maintenance Procedures for the Guidance for Industry Q3C Procedures/Recommendations 02/11/02
International Conference on Harmonisation - Quality Q3C Appendix 4  (PDF - 120KB) Draft Guidance 03/18/98
International Conference on Harmonisation - Quality Q3C Appendix 5 (PDF - 216KB) Draft Guidance 03/18/98
International Conference on Harmonisation - Quality Q3C Appendix 6 (PDF - 128KB) Draft Guidance 03/18/98
International Conference 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 Conference on Harmonisation - Quality Q4B: Annex I: Residue on Ignition/Sulphated Ash General Chapter  (PDF - 36KB) Final Guidance 02/20/07
International Conference on Harmonisation - Quality Q4B: Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter (PDF - 79KB) Final Guidance 01/08/09
International Conference on Harmonisation - Quality Q4B: Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter  (PDF - 1.2MB) Final Guidance 01/08/09
International Conference 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 Conference 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 Conference 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 Conference on Harmonisation - Quality Q4B: Annex 5: Disintegration Test General Chapter (PDF - 85KB) Final Guidance 12/22/09
International Conference on Harmonisation - Quality Q4B: Annex 6: Uniformity of Dosage Units General Chapter  (PDF - 53KB) Final Guidance 06/13/14
International Conference on Harmonisation - Quality Q4B: Annex 7(R2): Dissolution Test General Chapter (PDF - 102KB) Final Guidance 06/23/11
International Conference on Harmonisation - Quality Q4B: Annex 8: Sterility Test General Chapter (PDF - 84KB) Final Guidance 12/22/09
International Conference on Harmonisation - Quality Q4B: Annex 9: Tablet Friability General Chapter (PDF - 84KB) Final Guidance 04/02/10
International Conference on Harmonisation - Quality Q4B: Annex 10: Polyacrylamide Gel Electrophoresis General Chapter (PDF - 84KB) Final Guidance 04/09/10
International Conference on Harmonisation - Quality Q4B Annex 11: Capillary Electrophoresis General Chapter (PDF - 93KB) Final Guidance 09/02/10
International Conference on Harmonisation - Quality Q4B Annex 12: Analytical Sieving General Chapter (PDF - 87KB) Final Guidance 09/01/10
International Conference on Harmonisation - Quality Q4B Annex 13: Bulk Density and Tapped Density of Powders General Chapter (PDF - 94KB) Final Guidance 05/24/13
International Conference on Harmonisation; Quality Q4B Annex 14: Bacterial Endotoxins Test General Chapter (PDF - 96KB) Final Guidance 10/15/13
International Conference 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 Conference 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 Conference on Harmonisation - Quality Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products (PDF - 70KB) Final Guidance 07/01/96
International Conference 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 Conference on Harmonisation - Quality Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process (PDF - 58KB) Final Guidance 06/01/05
International Conference 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 Conference on Harmonisation - Quality Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (PDF - 54KB) Final Guidance 08/01/99
International Conference 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 Conference on Harmonisation - Quality Q8(R2) Pharmaceutical Development (PDF - 402KB) Final Guidance 11/20/09
International Conference on Harmonisation - Quality Q9 Quality Risk Management (PDF - 113KB) Final Guidance 06/01/06
International Conference on Harmonisation - Quality Q10 Pharmaceutical Quality System (PDF - 274KB) Final Guidance 04/07/09
International Conference on Harmonisation - Quality Q8, Q9, and Q10 Questions and Answers (PDF - 185KB) Final Guidance 11/01/11
International Conference 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 Conference on Harmonisation - Quality Q11 Development and Manufacture of Drug Substances (PDF - 708KB) Final Guidance 11/19/12
International Conference on Harmonisation - Quality Q3D Elemental Impurities (PDF - 811KB) Draft Guidance 10/15/13

Page Last Updated: 07/10/2015
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