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Guide to Inspections of Viral Clearance Processes for Plasma Derivatives.


PB98137144

Publication Date 1998
Page Count 14
Abstract This document attempts to provide basic information on viral clearance validation concepts, to enable the investigator to distinguish those areas of viral clearance processes that are appropriate for GMP inspection coverage. it is not an all-encompassing technical guide on viral inactivation processes, but rather a document that seeks to assist field investigators in conducitng fractionator inspections.
Keywords
  • Plasma derivatives
  • Viral clearance
  • Inspections
  • Validation
  • Processes
  • Food and Drug Administration
Source Agency
  • Office of Management and Operations
Corporate Authors Food and Drug Administration, Rockville, MD. Div. of Emergency and Investigational Operations.
Document Type Technical Report
NTIS Issue Number 199814
Guide to Inspections of Viral Clearance Processes for Plasma Derivatives.
Guide to Inspections of Viral Clearance Processes for Plasma Derivatives.
PB98137144

  • Plasma derivatives
  • Viral clearance
  • Inspections
  • Validation
  • Processes
  • Food and Drug Administration
  • Office of Management and Operations
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