WHO: TRS 1060 Nitrosamine Guideline published

In April 2025, the WHO published the new TRS 1060 guideline package on its website, enabling us to provide an overview of the key topics covered in the associated annexes (Annexes 2 to 9) in a news article. These include ‘TRS 1060 - Annex 2: WHO good practice considerations for the prevention and control of nitrosamines in pharmaceutical products’, which must be taken into account by manufacturers and packagers of excipients, active ingredients, processing aids and finished medicinal products. It should be noted that WHO Annex 2 is to be regarded as a supplement to the existing GMP guidelines and their requirements with regard to nitrosamines, as set out in ICH M7 (R2), for example.

The individual chapters of Annex 2 are listed below:

Abbreviations
1. Introduction
2. Scope
3. Glossary
4. Points to be considered in the control of nitrosamine impurities
5. Risk assessment
6. Root cause analysis
    6.1 Amines and nitrite reaction
    6.2 Amine functional groups in processing
    6.3 Introduction of nitrosamine impurities
    6.4 Fresh or recovered raw materials, including solvents
    6.5 Water
    6.6 Environmental air and contamination
    6.7 Quenching process as a source of nitrosamine contamination
7. Risk control strategy
8. Excipients and packaging material
9. Active pharmaceutical ingredients (APIs)
10. Finished pharmaceutical product (FPP) manufacturers
11. Acceptable intake limits
12. Analytical procedures
13. Summary and recommendations
References
Appendix 1 Examples of interim allowable daily intake limits for a selection of
N-nitrosamine impurities 118
Appendix 2 Risk assessment and root cause analysis 

You can view 'TRS 1060 – Annex 2: WHO Good Practice Considerations for the Prevention and Control of Nitrosamines in Pharmaceutical Products' on the WHO website.