Development of a Biological Handbook: A Reference Guide for Regulatory Considerations of Biological Products
Garcia, Sherilyn D.
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The broad range of chemical and biological compliance standards has resulted in a complex, multifaceted regulatory environment for the development and distribution of biological products. Due to this complexity, company processes are challenged with the task of developing procedures to meet the technical regulatory requirements, but still allow personnel to consider cross-functional business applications. The conceptualization of this regulatory model can be increasingly difficult for new or less experienced personnel for the reason of a lacking foundation of fundamental regulatory elements. Thus, the purpose of this Capstone Project was to create a biological handbook that can be used as a reference guide for regulatory considerations of biological product. This handbook was designed to bridge the knowledge gap between developing procedures and providing appropriate resources and basic information for key personnel. The development of this handbook required the compilation of current regulations and Company processes, to then delineate, to use as a reference tool specific to the Texas logistic center. Guidance documents published by regulatory agencies were reviewed and provided useful interpretations of otherwise dense regulations. A search for other broad reference documents related to biological substance organization was unsuccessful. Each chapter provides a different regulatory aspect of biological products, some of which would require trigger collaboration between business functions. The project resulted in the creation of handbook, intended to provide basic information that may apply to biological operations conducted at the current logistics center and internationally transported, especially to Germany and South Korea.