Temperature monitoring requirements for Pharmaceutical cold-chain logistics
Pharmaceutical cold-chain logistics
The need for complete visibility of goods during chilled transportation is becoming a more common request by pharmaceutical organisations in present days, not just to meet the strict regulatory guidelines set for the pharmaceutical sectors, but as a way to ensure valuable stock isn’t lost during the last leg of its logistical-production system.
But what is actually expected from MHRA when it comes to shipment? Inspections are made to ensure that organisations comply with Good Distribution Practices (GDP). As long as your products are consistently stored, transported and handled under suitable conditions, required by marketing authorisation (MA) you will comply. So how do you obtain logistical environmental data to know your products still comply?
There are three possible solutions to this potential gap in data;
- Ensure your outsourced logistics company agrees to share temperature monitoring data with you for the duration of the products delivery. A guide to what to ask your outsourced logistics company can be found here.
- Use cost-effective temperature monitoring data loggers with all your products during transit.
- Monitor your products using a wireless monitoring system.
All of the above solutions will satisfy MHRA auditors, but the third option may actually play an even more valuable role to pharmaceutical organisations.
If you can obtain real-time data via cloud-based software and retrieve alarms via email or SMS to designated personnel, you’d be in a pretty good position to prevent damage from occurring altogether let alone exceed MHRA requirements.
For information on data loggers or wireless systems specifically for Pharmaceutical cold-chain logistics, please contact us today.