La gestion des OOS au cœur de cette injonction....
Dans le cas de ce fabricant d'API chinois, le traitement des résultats en dehors des critères d'acceptation constitue un écart majeur : 1. Failure to adequately investigate and document out-of-specification results according to a procedure, and implement appropriate corrective actions. Our investigator found that your firm repeatedly, and without justification, resampled and retested crude heparin batches when your quantitative polymerase chain reaction (Q-PCR) test for ruminant DNA exceeded your established specification limit of ≤ (b)(4) parts per million (ppm). As a result, your firm used crude heparin batches that potentially were out-of-specification (OOS) to manufacture heparin sodium API for the U.S. market. 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. Ruminant DNA Q-PCR test results for batch Y102-1504005