ABSTRACT
In a series of inspections over two years, the Food and Drug Administration (FDA) cited Barr Laboratories with a number of pharmaceutical Good Manufacturing practice deficiencies. The FDA’s position to the court was that any out-of-specification (OOS) result generated during laboratory testing represents a batch failure. Although the Barr case dealt with a drug maker, points stemming from court decision may be of some value to other industries where quality control (QC) testing is critical in determining whether the finished product is of sufficient quality to permit release to the marketplace. If the initial, informal investigation is inconclusive or shows that there was no obvious or gross laboratory error, then a formal investigation is performed within the QC laboratory. The laboratory investigation document must be driven by appropriate Standard Operating Procedures that govern the process, and these investigations must clearly present all necessary laboratory information associated with the OOS result and its aftermath.
