- What do we need to do to ensure compliance with the PSI and HPRA/EU GDP Guidelines on storage and transport of medicinal product?
- Why do we need to monitor the temperature in the dispensing/storage areas and that of product deliveries?
- Why do we need Calibration? What are HPRA requirements for Calibration?
- How do I manage Calibrations?
What do we need to do to ensure compliance with the PSI and HPRA/EU GDP Guidelines on storage and transport of medicinal product?
To comply with these guidelines you are required to have the relevant Quality Management System in place and to use calibrated temperature /humidity monitoring instrumentation to record environmental temperature/humidity data for the dispensing and storage areas including the pharmacy refrigerator. You are also required to ensure that all medicinal product delivered to you has been transported at and arrives at the correct temperature.
Why do we need to monitor the temperature in the dispensing/storage areas and that of product deliveries?
This is to ensure and confirm that medicinal product is transported and stored in accordance with label requirements and thus ensure patient safety.
Why do we need Calibration? What are HPRA requirements for Calibration?
Temperature Sensors [probes; data loggers] require regular calibration to ensure that they are still operating within their stated accuracy specification. The HPRA requires that all sensors are calibrated annually at three temperature points across the temperature range that they are being used at.
Rototherm will remind you when your equipment is due for calibration. Simply send your temperature/ humidity loggers and meters in to Rototherm and we will take it from there. Calibrations are all traceable to National Standards and carried out on three temperature points over their usage scale.
