Quality
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Should you have any questions or comments regarding the content of the guidance documents found on this page please contact:
Health Canada – ICH Coordinator
Email: hc.ich.sc@canada.ca
Q1: Stability testing
- Q1A(R2): Stability Testing of New Drug Substances and Products [2003-09-25]
- Q1B: Stability Testing: Photostability Testing of New Drug Substances and Products [1999-02-12]
- Q1C: Stability Testing: Requirements for New Dosage Forms [1998-09-01]
- Q1D: Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products [2003-09-25]
- Q1E: Evaluation of Stability Data [2003-09-25]
Q2: Analytical Validation
Q3: Impurities
- Q3A(R2): Impurities in New Drug Substances [2015-06-05]
- Q3B(R2): Impurities in New Drug Products [2015-06-15]
- Q3C(R8): Impurities: Guideline for Residual Solvents [2021-06-04]
- Q3D(R1): Guideline for elemental Impurities [2019-05-31]
Q4: Pharmacopoeias
- Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions [2010-09-29]
- Q4B Annex 1(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Residue on Ignition/Sulphated Ash General Chapter [2010-10-13]
- Q4B Annex 2(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations General Chapter [2010-10-13]
- Q4B Annex 3(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles General Chapter [2010-10-13]
- Q4B Annex 4A(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter [2010-10-13]
- Q4B Annex 4B(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter [2010-10-18]
- Q4B Annex 4C(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter [2010-10-20]
- Q4B Annex 5(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test General Chapter [2010-10-22]
- Q4B Annex 6(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test General Chapter [2015-05-29]
- Q4B Annex 7(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Dissolution Test General Chapter [2010-10-22]
- Q4B Annex 8(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Dissolution Test General Chapter [2010-10-26]
- Q4B Annex 9(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Tablet Friability General Chapter [2010-10-26]
- Q4B Annex 10(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Polyacrylamide Gel Electrophoresis General Chapter [2010-10-26]
- Q4B Annex 11(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Capillary Electrophoresis General Chapter General Chapter [2015-05-29]
- Q4B Annex 12(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Regions on Analytical Sieving General Chapter [2015-06-03]
- Q4B Annex 13(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bulk Density and Tapped Density of Powders General Chapter [2015-05-29]
- Q4B Annex 14(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bacterial Endotoxins Test General Chapter [2015-05-29]
Q5: Quality of Biotechnological Products
- Q5A: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin [2001-01-05]
- Q5B: Quality of Biotechnological Products: Analysis of the Expression Construct in Cells used for Production of R-DNA Derived Protein Products [2001-01-05]
- Q5C: Quality of Biotechnological Products: Stability Testing of biotechnological / Biological Products [2001-01-05]
- Q5D: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological / Biological Products [2001-01-05]
- Q5E: Comparability Of Biotechnological/Biological Products Subject To Changes In Their Manufacturing Process [2015-06-15]
Q6: Specifications
- Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances [2016-01-29]
- Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological / Biological Products [2001-12-20]
Q7: Good Manufacturing Practice
Q8: Pharmaceutical Development
- Q8(R2): Pharmaceutical Development [2016-02-11]
Q9: Quality Risk Management
- Q9: Quality Risk Management [2016-02-05]
Q10: Pharmaceutical Quality System
- Q10: Pharmaceutical Quality System [2016-02-17]
- Q8, Q9 and Q10 Questions & Answers (R4) [2016-02-05]
Q11: Development and Manufacture of Drug Substances
- Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) [2016-02-12]
Q12: Lifecycle Management
- Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management [2021-11-29]
- Q12: Health Canada's implementation of ICH Q12 pilot program [2021-11-05]
Cross-cutting Topics
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