A six-sigma approach to stability testing.
The following defines stability testing in the diagnostic and pharmaceutical industries as a process which, depending on the manufacturer's current approach, may contain many opportunities for improvement. Statistical thinking and six sigma concepts will enhance stability testing process capability and lead to higher confidence in the data. Tools for set up and the rationale behind them are provided to assist in establishing appropriate criteria and volume of testing.
De Vore
Karl
K
Bio-Rad Laboratories, Irvine, CA 92688, USA. karl_devore@bio-rad.com
D002627:Chemistry, Physical / Q000379:methods*; D016001:Confidence Intervals; D003954:Diagnostic Services / Q000706:statistics & numerical data*; D004345:Drug Industry / Q000379:methods*; D004355:Drug Stability; D017598:Efficiency, Organizational; D015233:Models, Statistical; D011336:Probability; D011786:Quality Control; D012044:Regression Analysis; D012107:Research Design; D013696:Temperature; D013997:Time Factors; D014481:United States