Stability Program Management, Clinical Trial Materials: PTC When Using a Contract Stability Lab”

March 22, 2011 - PRLog -- AGAWAM, MASS. – March 22, 2011 – A new, free white paper titled “Stability Program Management, Clinical Trial Materials: PTC When Using a Contract Stability Lab” is now available for download from Microtest Laboratories at http://www.microtestlabs.com/stability-program-paper.

Many virtual clinical manufacturers, as well as some nonvirtual companies, require a stability program but lack the brick-and-mortar facilities to operate a fully compliant and capable stability laboratory. Such firms will often outsource their programs to third-party laboratories.

The new white paper details the critical issues that a manufacturer must address in starting and setting up a stability program with an outside contract laboratory. Much more than regurgitating the ICH guidelines, the paper’s discussion centers on the following key issues:
•   Initial communication with the contract stability laboratory or organization
•   Transfer of methods
•   Required product knowledge and stability program management
•   Data presentation for important decision making on label claims

The white paper reviews the development of a parenteral stability program from the standpoint of effective stability program management, rather than from a regulatory or scientific requirements perspective.

The paper is authored by Alex Mello, Director of Project Management, Manufacturing, and Jessica Labrie, Project Manager/Stability Coordinator, both of Microtest Laboratories.

Download a free copy of the white paper “Stability Program Management, Clinical Trial Materials: PTC When Using a Contract Stability Lab” from http://www.microtestlabs.com/stability-program-paper.

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About Microtest Laboratories
Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.