1. Failure to adequately investigate and document out-of-specification results according to a procedure, and implement appropriate corrective actions.
...For example, according to your Deviation Handling Sheet No.07-2015021, you resampled and tested crude heparin batch Y102-1504005 multiple times, with the following results.
You neither evaluated the initial sample OOS, nor conducted retesting of the initial original sample to confirm it. Instead, you resampled until you obtained a passing result.I love that last sentence.
Similarly, your initial test results for another crude heparin batch (Y102-1503008) were also OOS. Again, you resampled without justification, and accepted the batch when you obtained results within specification.
Disregarding the OOS results, and resampling and retesting without scientific justification, constitutes “testing into compliance.” This practice is unscientific and objectionable under CGMP....