The GMP-Z guideline sets strict requirements for how hospitals monitor the quality of drugs and medical devices. More and more hospitals are implementing this with concrete measures, or are looking for appropriate solutions that do meet the requirements.
One of the key components of this is temperature monitoring of drugs, vaccines and medical devices. Where that used to consist of loggers that were read after the fact, a real-time solution has now become the norm. In addition, you see real-time temperature monitoring increasingly moving toward an Environmental Monitoring Solution also known as an EMS. This solution is capable of measuring and monitoring virtually every quantity imaginable.
But what is GMP-Z really asking of a hospital or hospital pharmacy there? In practice, it is not just about complying with guidelines, but about carefully implementing, validating and securing them in daily work. This requires a lot of time and effort from staff, while that capacity is needed for the core of their work: patient care and medication safety.
Wat zegt de GMP-Z over temperatuurbewaking
The requirements of GMP-Z are clear: processes and storage conditions of temperature-sensitive products must be demonstrably under control. In practice, this means three things:
1. Continuous and reliable monitoring
Temperatures must be monitored in real time. Not incidentally or manually, but through an independent validated solution that automatically measures, records and alarms. Only then can deviations be detected and documented in a timely manner. Also, deviations and other actions must be clearly traceable.
2. Validation of the solution.
According to GMP-Z Annex 15, any form of temperature monitoring must be qualified and validated. Not only the hardware, but also the software and alarms must be included in the qualification (IQ, OQ and if necessary PQ). Also consider documents such as a Risk Assessment or User Requirement Specifications.
All steps must be demonstrably performed and documented, including risk analysis.
3. Periodic calibration
The measuring equipment used must be demonstrably accurate. Calibration at a set interval, including calibration certificates and insight into measurement deviations, is a fixed requirement. Preferably in a way that is manageable and as inexpensive as possible, because calibration is a good business model for many companies. What exactly periodic means is up to you and you can come up with a strategy based on reliability studies. A good partner will help you with this and ensure that no unnecessary calibration is required. This results in fewer interruptions and lower costs.
A tip: if possible, choose digital sensors instead of analog recorders. These are a lot more accurate by default and never deviate due to wear, damage or other external factors.
Dyzle offers a future-proof approach
What used to be seen as a stand-alone form of temperature monitoring has today evolved into a full-fledged Environmental Monitoring Solution (EMS). With it, we monitor not only temperature, but also relative humidity, pressure (difference) and particle concentration in full real time, centrally and validated. The strength of our solution lies in its unity: regardless of the type of sensor or application, the platform always works in the same way. Whether it is a medicine cabinet, a refrigerated truck or a laboratory environment, all users work in the same online environment. Of course, the users are optimally configurable so that they all can or may do exactly what belongs to their function role.
The technical department can also play a role in this, if desired. We find that some organizations want to actively involve their own technical department (TD) in calibration or local management, for example, while others prefer to outsource it completely. Both options are possible. Our solution is technically well integrated, and we support where necessary with clear documentation, practical instructions and on-site training. This keeps the approach manageable with or without support from your own TD.
As a Dutch company, we help hospitals with a validated temperature monitoring solution that is fully GMP-Z compliant, without unnecessary complexity and cost-conscious.
Our solution:
- Monitors temperature, relative humidity, pressure (difference) and particles in real time with instant alarm notification via email, SMS or push notification via the free Dyzle App.
- Is validated according to GxP guidelines including all documentation including IQ/OQ. Within 2 business days we can validate your complete Dyzle installation.
- Makes calibration easy and manageable with extended calibration interval and the ability to perform your own calibrations. Reliability studies are available to you.
- Has a long lifespan the hardware lasts over 15 years and the software is constantly being developed and improved. Updates are free and you don’t have to install anything locally.
- Is audit proof if you choose Dyzle never gets a comment from the auditing agencies regarding EMS again.
In doing so, you do not have to tear down existing wired sensor networks. We can often reuse them, so the transition to a full-fledged, modern and validated EMS can be achieved quickly and cost-effectively.
Why this matters
With Dyzle, you get the assurance of a validated EMS without sacrificing ease of use, flexibility or budget. GMP-Z requires partners who not only deliver, but also understand what is going on within the hospital. This is what we are committed to every day.
Want to know what this might look like within your organization? Let us know. We would love to think with you.
