Validation Practices for Biotechnology Products

Front Cover
J. K. Shillenn
ASTM International, 1996 - Technology & Engineering - 152 pages
Presents the current methods and practices by which companies that produce genetically altered drugs assure that all components and finished products have the identity, strength, quality, and purity that is purported and represented. Also considers possible improvements and whether industry standard
 

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Contents

Validation of Filters Used for Sterilizing Liquidsi m martin s cole
14
Points to Consider Before Validating a Liquid Nitrogen FreezerF p simione
24
Standards and Practices for Computer Validation and System Definition
31
Validation Studies in the Regeneration of IonExchange Celluloses
44
Sensitivity Considerations in Hydrophobic Filter Integrity Testing
56
Designing Validation into Chromatography Processesg k sofer
75
Developing Procedures to Meet GMP Requirementsm j malooley
83
Process Development ScaleUp and Validation of a Recombinant E Coli
97
A New Methodology for Quality Control Testing of Biological
107
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