The guideline helps manufacturers with questions they should answer regarding risk assessment and root cause analysis. It provides also examples of possible root causes.

There are separate sections for excipients and packaging materials, APIs and finished pharmaceutical products.

For establishing and setting acceptable intake (AI) limits the enhanced Ames Test (EAT) and the Carcinogenic Potency Categorization Approach (CPCA) are mentioned. For recommended AI limits the draft guideline refers to US FDA regulatory information.

Sections on analytical methods and recommendations complete the document.

The WHO’s draft guidance is open for comments until 9 June 2024.

Source:

WHO: WHO good manufacturing practices considerations for the prevention and control of nitrosamine contamination in pharmaceutical products