APIC: Update of the Nitrosamine Guide

The guideline 'Additional guidance on the assessment on the risk assessment for presence of N-nitrosamines in APIs', first published in February 2020, has now been revised by a subgroup of the 'APIC Nitrosamines Task Force' and recently published in its latest version on the APIC website. The document is now called 'Nitrosamine Risk Management: Guidance for API Manufacturers' and has been extensively updated.

The updated table of contents of the guideline contains the following 11 chapters and subchapters:

1. Foreword
2. Revision History
3. Purpose and Scope
4. Definitions and Abbreviations
    4.1. Definitions
    4.2. Abbreviations
5. Nitrosamine Risk Assessment
    5.1. General approach
    5.2. Nitrosamine Formation Mechanisms
       5.2.1. Direct use of Nitrosamines
       5.2.2. Nitrosation
          5.2.2.1. Raw Materials, Intermediates or APIs as Nitrosamine Precursors
          5.2.2.2. Potential for Contamination of Raw Materials with Nitrosamines and/or Nitrosamine Precursors
          5.2.2.3. Recovered materials
          5.2.2.4. Cross contamination from multi-purpose equipment
          5.2.2.5. Risks from Water
          5.2.2.6. Water Testing
          5.2.2.7. Risk of Leaching from Ion Exchange Resins
          5.2.2.8. NOx in air
       5.2.3. Oxidation
       5.2.4. Degradation
       5.2.5. Packaging
    5.3. Purge Assessment
6. API Testing
    6.1. Limit Calculation and Setting
    6.2. Test methodologies
    6.3. Confirmatory testing
    6.4. Control Strategy
7. Risk mitigation and CAPAs
8. Risk Assessment Conclusion
9. Presentation to Customers
10. Incorporation of Nitrosamine Risk management into the QMS
      10.1. Organizational Awareness / Training
      10.2. Regulatory Intelligence
      10.3. Supplier Quality Management
      10.4. Lifecycle management
11. References

One of the new chapters is Chapter 10 'Incorporation of Nitrosamine Risk management into the QMS', which is again divided into four sub-chapters. The complete guideline 'Nitrosamine Risk Management: Guidance for API Manufacturers', including all new features, can be found on the APIC website in the Publications tab.