Clinical Supplies Manufacture: GMP Considerations

Authored by: David L. Chesney

Encyclopedia of Pharmaceutical Science and Technology

Print publication date:  July  2013
Online publication date:  July  2013

Print ISBN: 9781841848198
eBook ISBN: 9781351124874
Adobe ISBN:

10.1081/E-EPT4-v1-37

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Abstract

In most worldwide regulatory venues, there is regulation of the manufacture of clinical trial materials (otherwise known as investigational drugs, investigational medicinal products, and by various other terms) under applicable Good Manufacturing Practice (GMP) standards. This chapter presents the concept of GMP applicability to clinical trial materials mainly with respect to U.S. Food and Drug Administration (FDA) standards, however, also included are summary cross-references to current European Union standards as administered by the European Medicines Agency (EMA) via the member States, and to the Canadian requirements.

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