ICH CMC GUIDANCES ----------------------------------------------------------------------------------------------- ICH Site ICH Guidance- Quality Topic Q1A Stability Testing of New Drug Substances and Products Topic Q1A Stability Testing: Stability Testing of New Drug Substances and Products Topic Q1B Photostability testing of New Active Substances and Medicinal products Topic Q1C Stability Testing: Requirements for New Dosage Forms Topic Q2A Validation of Analytical Methods: Definitions and Terminology Topic Q2B Validation of Analytical Procedures: Methodology Topic Q3A Impurities Testing: Impurities in New Drug Substances Topic Q3A Impurities Testing: Impurities in New Drug Substances Topic Q3B Impurities in New Drug Products Topic Q3B Impurities in New Medicinal Products Topic Q3C Impurities: Residual Solvents Topic Q5A Viral Safety Evaluation Topic Q5B Analysis of Expression Construct in Cell Lines Topic Q5C Stability Testing of Biotechnological/Biological Products Topic Q5D Derivation & Characterisation of Cell Substrates Topic Q6A Specifications: Chemical Substance - Test Procedures & Acceptance Criteria Topic Q6A Specifications: Decision Trees for Test Procedures & Acceptance Criteria Topic Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products