CGMP Requirements For Automated Facility Monitoring Systems

 

Monitoring systems (image by Tim Sandle)

In pharmaceuticals and healthcare, “facility” refers to the operational space, such as a cleanroom. The critical controls that maintain the facility are delivered through key utilities like air handling systems. To assess facility control, most organizations use facility monitoring systems (FMSs) to monitor the manufacturing workspaces continuously. Such systems are designed to be always on when the facility is in the operational state, ensuring compliance with important parameters across identified ranges. An important element for microbiological control is particle counting, which verifies the class of the cleanroom and indicates how well control is being maintained. Interconnected devices provide continuous monitoring of facilities, including aseptic and controlled environments. Other environmental data is also of importance for the contamination control strategy, including temperature, humidity, air velocity, and pressure. The design of these automated environmental monitoring systems should be based on quality risk management principles.

Sandle, T. (2023) CGMP Requirements For Automated Facility Monitoring Systems, Outsourced Pharma, August 2023: https://www.outsourcedpharma.com/doc/cgmp-requirements-for-automated-facility-monitoring-systems-0001

Also in:

BioProcess Online: https://www.bioprocessonline.com/doc/cgmp-requirements-for-automated-facility-monitoring-systems-0001
Pharmaceutical Online: https://www.pharmaceuticalonline.com/doc/cgmp-requirements-for-automated-facility-monitoring-systems-0001
Cell and Gene: https://www.cellandgene.com/doc/cgmp-requirements-for-automated-facility-monitoring-systems-0001
Biosimilar Development: https://www.biosimilardevelopment.com/doc/cgmp-requirements-for-automated-facility-monitoring-systems-0001
 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)