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.] |
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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Draft Guidance |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Draft Guidance |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Draft Guidance |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 |