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Apply ICH M7(R2) and ICH Q9 quality risk management principles demonstrating adequate control strategies, purge justification (e.g., Option 4), and risk-ranking of impurities. \n\n4.\tNitrosamine Risk Assessment:\n\n4.1.\tConduct a step-by-step nitrosamine formation risk assessment in alignment with the EMA\u2019s \"Guideline on the Limits of Genotoxic Impurities\", EMA/FDA Nitrosamine Guidelines, ICH M7(R2), and supporting Q&A documents. \n4.2.\tEvaluate potential nitrosamine precursors, nitrosating conditions, reagent/solvent compatibility, and formation pathways throughout the full synthetic route.\n4.3.\tProvide risk classification and recommendations for mitigation and control strategies consistent with global regulatory expectations.\n\nAll evaluations must be conducted following the principles outlined in ICH M7(R2) for mutagenic impurities, ICH Q3A(R2), ICH Q3B(R2), ICH Q7, and ICH S9 (where applicable to oncology products), as well as relevant EMA/FDA nitrosamine guidance, including the FDA's \"Risk Assessment of Nitrosamine Impurities in Human Drugs\" and associated Q&A documents.\nSelected bidder must provide the deliverables as results of the service. 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