GMP News No. 703
11 April 2006
of Computerised Systems -
Within the framework of GMP inspections of computerised systems, national and international supervisory authorities are especially interested in systems that acquire, archive and process critical GMP data (temperature, humidity, conductivity, TOC, particles and others) in the storage, production or control of medicinal products. In case a room monitoring system is not operated appropriately, sensitive medicinal products, like blood products, are at a high risk.
Numerous, partly grave deficiencies in connection with such systems have been documented during inspections. In the following, we have listed a selection of these deviations:
Unsatisfying configuration and documentation of systems for the acquisition of critical GMP-relevant parameters.
Paperless Videographic Recorders, Hybrid
Paperless Videographic Recorders, Data Flows
Monitoring System, Validation
Insufficient validation activities in connection with a system for temperature measurement in a cold storage leading to the preliminary rejection of the stored starting materials.
Data Loggers, Documentation
Printouts of data (graphs) based on data collected by data loggers are not precise enough to be used for a GMP-compliant evaluation.
Excel® Used as Evaluation Software, Data Conversion
The data generated by a logger were converted into the XLS format and archived without ensuring data integrity.
Room Monitoring System, Validation
Room Monitoring System, Projecting and Archiving
Backup of the data acquired by the room monitoring system was not conducted according to the state of the art. A documentation of the alert and system messages could not be presented.
Room Monitoring System, Access Control Matrix
The configuration of the user settings had considerable safety defects.
|The following GMP seminars also focus on new Computer Systems Validation issues:|
Office of the Tübingen Administrative District