ABSTRACT
An error is made in the laboratory. The analyst used a citrate buffer instead of the phosphate buffer specified by the procedure, a Good Manufacturing Practice (GMP) violation. It happens. Later that day, an out of specification (OOS) release result surprises everyone. The batch is quarantined and the procedures are checked to determine the sampling regime required to determine whether the OOS was a rogue test result or a genuine process problem. A few hours later, while the plant manager sleeps, an operator messes up the sequence for a batch set-up. The batch is scrapped and the shift supervisor checks her documentation to ensure the inevitable investigation is compliant, even if the batch is not.
