Logistical and Operational Practice in the Regulated Bioanalysis Laboratory

This chapter provides information on the internal and external logistics and practices required to operate a regulated bioanalytical laboratory. Despite commonality afforded by health authority guidances , the organizational structure of laboratories conducting regulated bioanalysis varies across the industry. For example, an internal bioanalytical laboratory operating within a pharmaceutical company is likely to be structured and operate significantly differently from a contract research organization (CRO) laboratory focused on the same discipline. From personal experiences, we can attest to the potential benefits for different operational structures, tools, and practices depending on the size and geographical footprint of a bioanalytical organization. Particularly, as a bioanalytical laboratory grows, the need to adapt to the scale of data handling, information management, and associated communications requires operational structures to evolve accordingly. These and other variables discussed in this chapter demonstrate the operational and logistical differences between different types of bioanalytical laboratories. Despite the structural differences, there are also some common logistical and operational requirements for all regulated bioanalytical laboratories including: (1) Information Technology (IT) systems that provide security, data management, and automation, (2) Standard Operating Procedures (SOPs) and policies that drive both regulated and business activities, (3) metric tracking that assists in both business operations and scientific operations, and (4) document and sample lifecycle management.