Affichage des articles du décembre, 2016

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