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APIC Releases Updated Nitrosamine Risk Management Guide
APIC has published an extensively revised version of its 2020 nitrosamine guidance, now titled "Nitrosamine Risk Management: Guidance for API Manufacturers." The updated document, prepared by the APIC Nitrosamines Task Force, offers expanded content and a structured approach to risk assessment and control of N-nitrosamines in APIs.
The guideline now includes 11 chapters, covering definitions, formation mechanisms (e.g., nitrosation, degradation, oxidation), testing, control strategies, CAPAs, and customer communication. A new Chapter 10 addresses integration of nitrosamine risk management into the Quality Management System, including training, supplier oversight, and lifecycle management.
This comprehensive guide provides practical tools for API manufacturers to meet regulatory expectations. The full document is available on the APIC website under the Publications section.
18-06-2025
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