Nitrosamines - new WHO guideline

The World Health Organization has prepared a new GMP guideline for the prevention and control of nitrosamine contamination in pharmaceuticals. The document is now in the working version in the comments procedure.

Document link:

qas24_943_gmp_nitrosamines_forpublic52f95166-1c71-4cc2-a499-05bc4967bf14.pdf ( who.int )

The new guidance as it stands is more detailed than the EMA and FDA documents.

FDA. Control of Nitrosamine Impurities in Human Drugs, Food and Drug Administration, September 2020: https://www.fda.gov/media/141720/download

EMA. Questions and answers for marketing authorization holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products – EMA/409815/2020 Rev.1:

https://www.ema.europa.eu/en/documents/referral/nitrosamines-emea-h-a53-1490-questions-answers-marketing-authorisation-holders-applicants-chmp-opinion-article-53-regulation- ec-no-726-2004-referral-nitrosamine-impurities-human-medicinal-products_en.pdf