National Technical Reports Library

Details

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

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