ICH Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products – Step 5
ICH Q6A: Specifications: Tests Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances – Step 5
ICH Q3B (R2): Impurities in New Drug Products – Step 5
ICH Q3A (R2): Impurities in New Drug Substances – Step 5
ICH M7 (R1): Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risks – Step 5
Question and answers on ICH M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risks
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