September 1999
ICH Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products – Step 5
May 2000
ICH Q6A: Specifications: Tests Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances – Step 5
June 2006
ICH Q3B (R2): Impurities in New Drug Products – Step 5
October 2006
ICH Q3A (R2): Impurities in New Drug Substances – Step 5
February 2018
ICH M7 (R1): Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risks – Step 5
July 2020
Question and answers on ICH M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risks
You can check Tox by Design methodology for Out of Specification reassessment, which are duly validated and signed by an European Registered Toxicologist expert.
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Feel free to contact us using the Quotation Request below to receive a quotation for Out of Specification reassessment, before or after Marketing Authorisation.