Regulatory Considerations for Controlling Intermediates in Type-II Drug Master Files for the Manufacture of Generic Drug Substances

March 15, 2016
David J. Skanchy

David J. Skanchy, PhD, is a review chemist with the US Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, tel. 240.276.8552, fax 240.276.8582.

,
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
Page Number: 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.

from Pharmaceutical Technology’s 2016 Solid Dosage Drug Development and Manufacturing eBook.

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