USP Workshop: Control of Nitrosamine and Other Mutagenic Impurities in Human Drugs

Agenda  Registration  Speaker bios

Virtual Workshop Format

In light of the COVID-19 pandemic, USP has decided to modify our approach to the workshop opting to hold a virtual meeting instead. We made this decision to both protect the health of our attendees, USP staff and speakers, and because we believe that we are obligated - as a mission-driven public health organization - to take steps to help slow the spread of this pandemic by fostering social distancing.


Since the outset of reports of nitrosamine impurities in certain drug products in June 2018, global regulatory and health agencies issued guidance documents to aid impacted stakeholders to conduct thorough analysis to assess and mitigate the risk introduced by the presence of nitrosamine impurities in drug substance and products. This workshop is intended to convene regulatory agencies, impacted stakeholders to share their perspectives and lessons learned, to facilitate the manufacturers understanding of regulatory expectations, and to be able to effectively adopt best practices in identifying the potential sources of nitrosamines, conducting the risk assessment, and developing the control strategies to help ensure the elimination or reduction of nitrosamine impurities in pharmaceutical products.


  • Virtual Zoom Meeting


  • May 27th, 2022, 8:30-18:30 China Standard Time UT+8:00 (Shanghai, China)


  • English-Chinese bilingual with simultaneous translation

Registration and Pricing Information

  • Free Registration
  • Registration deadline: May 26th, 2022

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Virtual Meeting