Regulatory Inspection Trends and Findings of Bioanalytical Laboratories

The absence of specific regulations related to bioanalytical laboratory testing of samples from human clinical trials provides for laboratory ambiguity of FDA compliance expectations. This variation in the interpretation of compliance expectations has led to various significant FDA inspectional findings leading to substantive enforcement actions against certain laboratories. This chapter provides a detailed analysis of current regulatory guidance and expectations based on reported inspectional trends, citations, and regulatory follow‐up letters. In addition, the regulatory compliance and scientific basis of these inspection citations are discussed, as applicable. Furthermore, specific recent FDA 483 observations and several current bioanalysis compliance “hot topics” that raised potential data integrity and other compliance concerns such as (a) the practices of using study samples for “preparation runs” or “equilibration runs”, (b) reinjection of samples at the end of run sequences to replace nonconformance quality control (QC) or standards, (c) event investigation practices, and (d) incurred sample reanalysis (ISR) requirements, are also extensively discussed.