Biomedical Engineering Reference
In-Depth Information
studies. Often this information is limited by the number of nonclinical and clinical
studies performed, as well as by the range of variation for an attribute in the batches
evaluated. As described here, in some cases prior product knowledge can be expanded
beyond these limitations by inducing an intentional increase in attribute variant levels,
followed by appropriate testing. Similarly, process capability information is limited to
the number of product batches manufactured by the relevant process and tested for the
attribute. Supportive information can be gleaned from similar processes for similar
products. Platform production processes, in which the same process is used for
production of multiple, similar products, can provide substantial amounts of predictive
information for process capability.
Thepurposeof this riskmanagement process is to identify themost appropriate testing
plan for each product quality attribute. Risk assessment provides a rationale for the testing
plan that enables efficient use of available resources, while assuring product quality.
ACKNOWLEDGMENTS
The authors gratefully acknowledge the outstanding technical and editorial contributions
made by Orit Scharf, Patrick McGeehan, Gerard Lacourciere, David Robbins, Yuan
Chang, ZipingWei, Robert Strouse, Patricia Cash, Jose Casas-Finet, and Harry Yang. We
would also like to thank Helen Jeanes, Nancy Craighead, and Anita Ymbert for their
expert assistance in preparing the manuscript.
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