title: A quantitative assessment of factors influencing the probability of postmarketing out-of-specification observations.
abstract: When marketed lots of pharmaceutical products produce a number of out-of-specification (OOS) samples, it can be very disruptive. In some cases such lots must be recalled, at substantial expense. We present a model of the probability of OOS samples and show quantitatively how this probability depends on the underlying variation and on the original stability study. We describe the limited situations in which sponsors can reduce the probability of OOS samples.
authors.affiliation: Flower Valley Consulting, Inc., Rockville, Maryland 20853, USA. fairweather@flowervalleyconsulting.com
authors.forename: William R
authors.initials: WR
authors.lastname: Fairweather
mesh_terms: D004355:Drug Stability; D015233:Models, Statistical; D011336:Probability; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*