Managing the Risk of Nitrosamine Impurities
Collaborative industry efforts have shed light on ways industry standards can help pharma companies better understand the risks nitrosamines pose to the supply chain.
IQ Consortium working groups have engaged in ongoing efforts to evaluate risk models and guidance documents to help increase pharma industry knowledge about these impurities.
Read this article in Pharmaceutical Technology's Regulatory Sourcebook March 2021 eBook.
Article Details
Pharmaceutical Technology
eBook: Regulatory Sourcebook,
March 2021
Pages: 28–35
Citation
When referring to this article, please cite it as T. Curran and J.P. Bercu, "Managing the Risk of Nitrosamine Impurities," Pharmaceutical Technology Regulatory Sourcebook eBook (March 2021).
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
