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Characterization and Management of Test and Control Articles

May 13, 2013 6:46 pm PDT

EXECUTIVE SUMMARY

Good laboratory practices (GLPs) define the basic requirements for characterizing test and control articles used in clinical
trials and studies (1). Additional information follows this regulation with regard to storage, distribution, identification, and
documentation requirements. However, the focus of these regulations does not detail the most expeditious ways to perform
these activities or define the extent of characterization not only required by the regulations, but for the needs of the sponsor.
This discussion provides additional insight into the mechanisms for performing compliant and useful characterization of test
and control articles.

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