Control of Mutagenic Impurities: Survey of Pharmaceutical Company Practices and a Proposed Framework for Industry Alignment

Christopher J. Borths,Mark D. Argentine,John Donaubauer,Eric Elliott,Jared Evans,Timothy T. Kramer,Heewon Lee,Rodney L. Parsons,Jeffrey C. Roberts,Gregory W. Sluggett,Andrew Teasdale,Michael Urquhart,Ke Wang,Ping Zhuang

Control of Mutagenic Impurities: Survey of Pharmaceutical Company Practices and a Proposed Framework for Industry Alignment

2021

Christopher J. Borths
Mark D. Argentine
John Donaubauer
Eric Elliott
Jared Evans
Timothy T. Kramer
Heewon Lee
Rodney L. Parsons
Jeffrey C. Roberts
Gregory W. Sluggett
Andrew Teasdale
Michael Urquhart
Ke Wang
Ping Zhuang

ICH M7 provides several risk-based control options to manage mutagenic and potentially mutagenic impurities (MI and PMIs) in the manufacture of pharmaceuticals. A Working Group in the International...

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Risk analysis (engineering)
Business

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