Nitrosamine/NDSRI Risk Assessment Tool – Drug Products
1. Drug Product Details
Drug Product Name:
Manufacturer Details:
2. API Details
Number of APIs used in the Drug Product:
3. Excipient Details
Number of Excipients used in the Drug Product:
4. Primary Packing Materials
Number of Primary Packing Materials (PPMs) involved:
5. Nitrosamine and NDSRI Risk Questionnaire
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Nitrosamine/NDSRI Risk Assessment Report - Drug Products
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