The World Health Organization (WHO) released draft guidance for comment this month on good manufacturing practices (GMP) for the prevention and control of contamination of nitrosamines, which are a probable human carcinogen.
The new GMP guideline applies to all manufacturers of excipients, active pharmaceutical ingredients (APIs), and finished pharmaceutical products. Among other things, the document covers definitions of nitrosamines, impurities currently causing concern, and performance of root cause analyses and risk assessments…
