03 Jul APIC updated the Nitrosamine Risk Management Guidance
Posted at 09:57h
in Blog
The guideline “Additional guidance on the assessment on the risk assessment for presence of N-nitrosamines in APIs”, first prepared in February 2020 by the APIC Nitrosamines Task Force on behalf of the Active Pharmaceutical Ingredient Committee (APIC), has now been revised by a subgroup of the APIC Nitrosamines Task Force to reflect latest guidance and recommended practice and recently published on the APIC website. The document is now called “Nitrosamine Risk Management: Guidance for API Manufacturers” and has been extensively updated.
Among the new features introduced, a separate chapter is dedicated to the incorporation of nitrosamine risk management into the quality management system.
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