Articles by Tim Schofield - Pharmaceutical Technology

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Articles by Tim Schofield

Overcoming Disincentives to Process Understanding in the Pharmaceutical CMC Environment

Larger and strategic sampling and testing plans can improve process understanding and characterization.
Sep 2, 2007
By: Laura Foust, Myron Diener, Mary Ann Gorko, Jeff Hofer, Gregory Larner, David LeBlond, Jerry Lewis, Dennis Sandell, Tim Schofield, Kim Vukovinsky, Ed Warner

Larger and strategic sampling and testing plans can improve process understanding and characterization.

Revisiting The Notion Of Singlet Testing Requirements

Jun 2, 2005
By: David LeBlond, Tim Schofield, Stan Altan

In his Feb. 2005 viewpoint article, "In Defense of Singlet Testing," Torbeck (1) draws an important philosophical distinction between "standards" and "specifications." He argues that specifications are criteria selected by manufacturers for statistical control of their products, whereas compendial standards are absolute requirements. This distinction is entirely compatible with modern concepts of statistical process control.

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