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 unit (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 years that it has been in use.

Your October 10, 2014 response confirmed that you have no records documenting qualification of the DAU. Because this equipment was never qualified or validated, it is unclear whether it accurately monitored the temperature in your incubation rooms. You indicated that you would requalify the DAU. We acknowledge the corrective actions and will verify them upon re-inspection.

6.    Your firm failed to establish appropriate controls over computers and related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel (21 CFR 211. 68(b)).

You lacked audit trails or other sufficient controls to facilitate traceability of the individuals who access each of the programmable logic controller (PLC) levels or Man-Machine Interface (MMI) equipment. You had no way to verify that individuals have not changed, adjusted, or modified equipment operation parameters.

Access to production equipment used in parenteral manufacturing and solid (b)(4) dosage forms used a password shared by four or five individuals to gain access to each individual piece of equipment and access level. During our inspection, your Executive Production and QA manager confirmed that the password was shared. Neither your operators nor your supervisors had individual passwords.

During our inspection, firm officials also confirmed that you had not established or documented a control program to describe the roles and responsibilities of production equipment system administrators. There was also no record documenting the individuals who have access to the production equipment or the manner in which individual personnel access production equipment.

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