A Regulatory Perspective on Manufacturing Processes Pertaining to Lyophilized Injectable Products

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Steve Y Rhieu1, David D Anderson2, Kumar Janoria2

  • 1Office of Pharmaceutical Manufacturing Assessment, Office of Pharmaceutical Quality, Center of Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20993, USA. steve.rhieu@fda.hhs.gov.

The AAPS Journal
|August 4, 2020
PubMed

Keywords:
deficienciesfreeze-dryinginjectablelyophilizationunit operation

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