Écarts majeurs sur la maîtrise des systèmes automatisés pour ce laboratoire indien
La US FDA vient de publier une mise en demeure à l'encontre de ce laboratoire indien pour plusieurs manquements dont certains portent sur la maîtrise et la traçabilité des accès aux systèmes automatisés: 5. Your firm failed to routinely calibrate, inspect, or check according to a written program designed to assure proper performance and to maintain adequate written records of calibration checks and inspections of automatic, mechanical, or electronic equipment, including computers, used in the manufacture, processing, packing, and holding of a drug product (21 C.F.R 211.68(a)). Since 2005, you have been using an un-validated and unqualified Agilent data acquisition un it (DAU) to monitor the temperature of the microbiological incubation rooms for media filled vials. During our inspection, your quality engineer officer and QA manager stated that the DAU has not been qualified, and that you have not used a preventative maintenance schedule for this equipment during the nine
