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Regulatory Considerations for Controlling Intermediates in Type-II Drug Master Files for the Manufacture of Generic Drug Substances
Published on:
David J. Skanchy, Kandasamy Subburaj, Srinivasa Murthy, Humcha Hariprakasha, Brian T. Connell, Huyi Zhang, Deborah F. Johnson
Pharmaceutical Technology, Pharmaceutical Technology-03-15-2016, Volume 2016 eBook, Issue 1
Pages: s46-s54
The authors present analysis of the state of control of intermediate identity and quality, based on analysis of recently submitted DMFs.
The authors present analysis of the state of control of intermediate identity and quality, based on analysis of recently submitted DMFs.
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from Pharmaceutical Technology’s 2016 Solid Dosage Drug Development and Manufacturing eBook.
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