Establish a Transparent Chain-of-Custody to Mitigate Risk and Ensure Quality of Specialized Samples.

Abstract

Pharmaceutical research and development has entered a new era, shifting from the one-size-fits-all approach of traditional medicine to patient-specific therapeutics. This change in treatment methodologies has placed an increased emphasis on well-preserved, well-documented biospecimens. Due to these advancements in medicine, specimen handling processes need to be in accordance with current Good Practice (GXP) quality guidelines and regulations, including Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and Good Clinical Practices (GCPs), to ensure the safety of valuable biospecimen samples and their associated data. GXP guidelines delineate most aspects of clinical research. This is especially true for chain-of-custody documentation, as it provides a traceable record that guarantees unbroken control over a document, raw data, or a sample and its containers from initial collection to final disposition. Although establishing chain-of-custody can be a demanding practice, the process of verifying who has possession of specimens can be streamlined if an organization outlines chain-of-custody guidelines in their Standard Operating Procedures (SOPs). These processes and procedures ensure uniform application of best practices and successful knowledge transfer. As such, this article will outline the necessary components of establishing a highly visible and compliant chain-of-custody, including: maintaining 21 CFR Part 11 compliance; installing validated, redundant equipment for specimen storage and transportation; employing temperature-monitoring and -tracking devices; and best practices for implementing inventory and data management systems as well as audit trails.