Managing the Risk of Nitrosamine Impurities
Publication
Article
Pharmaceutical TechnologyPharmaceutical Technology-03-15-2021
Volume 2021 eBook
Issue 1
Pages: 28–35
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).
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It Takes a Bio/Pharma Village
Enabling the Virtual Human Through Physiologically-based Pharmacokinetic Modeling
Managing the Risk of Nitrosamine Impurities
Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based Strategies
Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug Development
Collaborative Efforts Address Key Data Integrity Challenges
Can FDA Reinvent Inspections
FDA 2021 Guidance Agenda Sees Focus on Generics
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Regulatory and Standard Setting Organizations Directory
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