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.

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
Online-Zugang:	Volltext
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