Invalidating Assay and Bioassay results in Compliance with Laboratory Data Integrity

Raphael Bar, BR Consulting, Israel, Israel

In recent years, regulatory inspections revealed that some pharmaceutical companies practiced unofficial sample testing or trial-testing prior to the final sample testing and reporting.  Invalidating these ‘trial” test results is suspected as implementing the unacceptable practice of “testing to compliance”.  Multiple analyses of the same sample without adequate justification are viewed as a data integrity problem.  Laboratory data integrity implies that all data is complete, accurate and consistent.

This presentation will first review the methodology of generating test results in a regulated pharmaceutical laboratory while addressing the suitability tests for both the measuring system and analytical procedure.  Then, the circumstances for correctly invalidating assay and bioassay results will be addressed.