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ICH Quality Guidelines
Table of Content

Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.

Q1A - Q1E Stability

Q1A(R2) _{Stability Testing of New Drug Substances and Products}

Q1B _{Stability Testing: Photostability Testing of New Drug Substances and Products}

Q1C _{Stability Testing for New Dosage Forms}

Q1D _{Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products}

Q1E _{Evaluation of Stability Data}

Q2 Analytical Validation

Q2(R2) _{Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation}

Q3A - Q3D Impurities

Q3A(R2) _{Impurities in New Drug Substances}

Q3B(R2) _{Impurities in New Drug Products}

Q3C(R9) _{Guideline for Residual Solvents}

Q3D(R2) _{Guideline for Elemental Impurities}

Q4B Pharmacopoeias

Q4B _{Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions}

Q5A - Q5E Quality of Biotechnological Products

Q5A(R2) _{Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin}

Q5B _{Analysis of the Expression Construct in Cell Used for Production of r-DNA Derived Protein Products}

Q5C _{Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products}

Q5D _{Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products}

Q5E _{Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process}

Q6A - Q6B Specifications

Q6A _{Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances}

Q6B _{Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products}

Q7 Good Manufacturing Practice

Q7 _{Good Manufacturing Practice Guide for Active Pharmaceutircal Ingredients}

Q8 Pharmaceutical Development

Q8(R2) _{Pharmaceutical Development}

Q9 Quality Risk Management

Q9(R1) _{Quality Risk Management}

Q10 Pharmaceutical Quality System

Q10 _{Pharmaceutical Quality System}

Q11 Development and Manufacture of Drug Substances

Q11 _{Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)}

Q12 Lifecycle Management

Q12 _{Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management}

Q13 Continuous Manufacturing of Drug Substances and Drug Products

Q13 _{Continuous Manufacturing of Drug Substances and Drug Products}

Q14 Analytical Procedure Development

Q14 _{Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation}