The Danish Medicines Agency's storage requirements
What applies in Denmark to the storage of medicines, and what an inspection typically asks about.
What does the Danish Medicines Agency require of temperature monitoring?
The Danish Medicines Agency supervises that medicines are manufactured, stored and distributed responsibly. The requirements are based on the EU rules, that is GMP for manufacturing and GDP for storage and distribution, and apply to pharmacies, hospital pharmacies, wholesalers and manufacturers.
For temperature monitoring, this means storage conditions must be under control and documented. At an inspection you will typically be asked to show a specific measurement at a specific time, how a deviation was handled, and when the sensor was last calibrated.
It is rarely the figures themselves that lead to findings. It is gaps in the documentation, deviations without a recorded response, and sensors without a valid calibration certificate.
Assessing whether your practice meets the requirements is up to you or your QA. We supply the system and the documentation.
What an inspection typically asks about
Show me 14 March
A specific measurement at a specific time. That requires data to be time-stamped and retrievable.
What happened at the deviation
Who was notified, when it was acknowledged, and what was done. All of it recorded.
When was the sensor calibrated
A certificate with serial number and date, and an interval that has been kept.
Why is the sensor placed there
Without a mapping study the answer is an estimate. With a study it is data.
Can the log be changed
A log that can be edited is not documentation. The audit trail must be unaltered.
Who has access
Named users with the permissions their role requires.
What most often leads to findings
Gaps in the graph, because a sensor had been sent for calibration or lost its connection. Deviations without a recorded response, because the alarm only went to an email nobody read. And sensors whose calibration interval has been exceeded. All three are system problems, not attitude problems, and all three can be solved with the setup.
Frequently asked questions
Does the Danish Medicines Agency require a specific system?
No. The requirement is that conditions are under control and can be documented. How you do it is up to you.
How long do we need to keep data?
That follows from your own procedures and the rules that apply to you. The system stores the data, and it can be exported as PDF and CSV.
Do the departments' refrigerators need monitoring too?
That is decided by your risk assessment. If medicines are stored there, they are in principle subject to the same requirements.
What if we receive a finding?
The system can document what actually happened and what was done. That is often what decides whether a finding stands.
Who helps us with the assessment itself?
Your QA or an external consultant. We supply the system and the documentation, not the regulatory assessment.
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