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
System
Unclear distinction between electronic record and paper documentation
(operation of hybrid systems), especially with regard to archiving and
evaluation.
Paperless Videographic Recorders, Data Flows
Data integrity endangered by untraceable data flows from the
acquisition of a measured value to its recording in a LIMS.
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
The qualification and validation of the room monitoring system was
insufficient. Internal calculations executed by the software in use were
not comprehensible.
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.
Data Loggers, Software for Evaluation and Archiving
GMP-relevant setup settings of an evaluation and archiving software
for data loggers were either not used or ignored.
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