WHO: Draft for the Prevention and Control of Nitrosamine Contamination

The World Health Organization (WHO) has released a new preliminary guideline outlining considerations for preventing and managing nitrosamine contamination in pharmaceutical goods. This guideline is applicable to all manufacturers involved in excipients, active pharmaceutical ingredients (APIs), and finished pharmaceutical products.

It assists manufacturers in addressing risk assessment and root cause analysis by posing pertinent questions and offering examples of potential root causes. The guideline is segmented into distinct sections covering excipients and packaging materials, APIs, and finished pharmaceutical products.

To establish acceptable intake (AI) limits, the guideline suggests employing the Enhanced Ames Test (EAT) and the Carcinogenic Potency Categorization Approach (CPCA). For recommended AI limits, it directs readers to regulatory information from the US Food and Drug Administration (FDA).

Additionally, the document includes sections on analytical methods and provides recommendations. Feedback on the WHO's draft guidance is welcomed until June 9, 2024.