V:
A documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting predetermined acceptance criteria.
See conformance lots
Potential or propensity to vary.
C. Julien and W. Whitford in BioProcess International "Hitchhikers"s Guide" to Bioprocess Design, March 2008, http://www.bioprocessintl.com/multimedia/archive/00078/BPI_A_080603SUPAR07__78643a.pdf
A change in data, characteristic or function caused by one of four factors: special causes, common causes, tampering or structural variation.
American Society for Quality - ASQ, U.S., Milwaukee, WI, viewed: March 2012, http://asq.org/glossary/
W:
A process whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality and which has a low risk of falling outside the design space.
CMC-Biotech Working Group A-Mab: a Case Study in Bioprocess Development, Version 2.1, 30. October 2009, http://www.ispe.org/pqli/a-mab-case-study-version-2.1
Chemical entities whose identity, purity, impurities, potency, and quantity can be determined and controlled.
C. Julien and W. Whitford in BioProcess International "Hitchhikers"s Guide" to Bioprocess Design, March 2008, http://www.bioprocessintl.com/multimedia/archive/00078/BPI_A_080603SUPAR07__78643a.pdf
XYZ:
The quantity of material or the percentage of theoretical yield anticipated at any appropriate phase of production based on previous laboratory, pilot scale, or manufacturing data.
