Procedural elements involved in maintaining bioanalytical data integrity for good laboratory practices studies and regulated clinical studies

Abstract

This article describes procedural elements involved in ensuring the integrity of bioanalytical data. These elements can be divided into 3 areas. First, there are those ensuring the integrity of the analyte until analysis, through correct sample collection, handling, shipment, and storage procedures. Incorrect procedures can lead to loss of analyte via instability, addition of analyte through contamination or instability of related metabolites, or changes in the matrix composition that may adversely affect the performance of the analytical method. Second, the integrity of the sample identity needs to be maintained to ensure that the final result reported relates to the individual sample that was taken. Possible sources of error include sample mixup or mislabeling, or errors in data handling. Finally, there is the overall integrity of the documentation that supports the analysis, and any prestudy validation of the method. This includes a wide range of information, from paper and electronic raw data, through standard operating procedures and analytical procedures and facility records, to study plans and final reports. These are critical to allow an auditor or regulatory body to reconstruct the study.

Biomarker method validation in anticancer drug development

“…While there appears to be no requirement for laboratories conducting biomarker analyses to comply to a full QA system like GCLP in the United States, several key publications have recommended adopting significant elements of a quality system, such as patient sample tracking, SOPs, analytical plans, facilities fit for purpose, study reports, compliance with FDA regulations on electronic records and signatures ( FDA, 1997 ) and certificates of analysis for standards ( James and Hill, 2007 ; Lee et al , 2007 ).…”

Issues on fit-for-purpose validation of a panel of ELISAs for application as biomarkers in clinical trials of anti-Angiogenic drugs

“…In the good laboratory practice (GLP) environment, extensive characterisation of sample stability is required by the regulators (James and Hill, 2007), and these should be conducted in a matrix that mimics the characteristics of the test samples (Nowatzke and Wood, 2007). Analyte depletion or a matrix that is otherwise altered is not considered acceptable to the FDA.…”

Competitiveness of Bioanalytical Laboratories— Technical and Regulatory Perspectives

“…Automation for sample handling meets the business needs of improving productivity and reducing the documentation required for compliance. Procedural elements involved in maintaining bioanalytical data integrity for good laboratory practices and regulated studies are discussed by James and Hill . The elements can be divided into three areas.…”