Depending on the activities of the dispensary, the monitoring system must comply with good manufacturing practice (GMP) standards. Whether monitoring is required also depends on medication preparation and storage within the dispensary. For cleanroom activities, monitoring of the pressurization regime is a minimal requirement.
Microbiological safety work stations, cytostatic work stations and filling carousels are being used increasingly often within a GMP environment. As some or all of the products being handled here fall under the GMP regime, these work stations also need to be reviewed for their compliance with requirements as described in Annex 1 of the EU GMP. A monitoring system can be used to demonstrate such compliance during general use and register any incidents, by monitoring a combination of requirements, correct use of the room and implementation of correct sampling positions (particles and pathogens).
Dispensary parameters to be monitored;
- Temperature and relative humidity within rooms (production, dispensary and preparation rooms) and of equipment (autoclaves, incubators, refrigerators, freezers)
- Pressure differential monitoring for all cleanrooms
- Particle measurements within cleanrooms, LAF cabinets and microbiological safety work stations, cytostatic work stations
- Measurements of colony-forming units (CFU) in LAF cabinets, microbiological safety work stations, cytostatic work stations