Statistical tools for setting in-process acceptance criteria

Statistical tools for setting in-process acceptance criteria

Regulatory approval and successful manufacturing depend on establishing meaningful and reasonable acceptance criteria for process validations and ongoing monitoring. Three methods to correct for the likely underestimation of process limits due to small samples are discussed.

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Bibliographische Detailangaben
Veröffentlicht in:Biopharm 2001-10, Vol.14 (10), p.28
Hauptverfasser: Seely, Robert J, Munyakazi, Louis, Haury, John
Format: Artikel
Sprache:eng
Schlagworte:
Biotechnology
Chromatography
Federal regulation
Manufacturing
Process controls
Regulatory approval
Statistical methods
Statistical process control
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Zusammenfassung:Regulatory approval and successful manufacturing depend on establishing meaningful and reasonable acceptance criteria for process validations and ongoing monitoring. Three methods to correct for the likely underestimation of process limits due to small samples are discussed.
ISSN:1542-166X
1939-1862