Monitoring of storage under GDP
Raw material stores, finished goods stores and cold rooms, where the temperature window has to be held across the whole room and not just where the sensor happens to be.
What does GDP require of temperature monitoring in a warehouse?
That medicines are stored within their temperature window, and that this can be documented. It applies to the whole room, not the middle. That is why GDP typically requires a mapping study showing where the warmest and coldest points are, after which the fixed sensors are placed exactly there.
In addition, there must be an alarm on deviation, a log that cannot be altered, and calibrated sensors with traceable certificates.
The number of measuring points and the limits are set according to your own risk assessment and your SOPs. We advise on placement based on mapping data.
The warmest point moves with the seasons
A warehouse is not one climate. There are differences between floor and ceiling, between back wall and loading door, and between a Friday in January and a Tuesday in July.
If you put the sensor where access is easiest, you are probably not measuring the spot where the goods are at risk. And at an inspection, the question is precisely how you know the sensor is in the right place.
The answer is a mapping study in summer and winter. It turns the placement into an argument instead of an estimate.
Summer and winter mapping →
What we monitor in the warehouse
Cold rooms and freezer stores
Several measuring points per room, placed according to mapping data and not according to where access is easiest.
Emerald Bluetooth sensor + Cobalt XRead about cold rooms and storage →
Ambient storage
Temperature and humidity in rooms without active cooling, where the outdoor temperature comes through.
Temperature and humidity sensor
Loading doors and airlocks
Dry contact on the loading door, so a long open load can be identified as the cause of the deviation.
Dry contact cable
Transport and shipping
Cool bags, boxes and trailers. Emerald measures all the way and is read via phone on receipt.
EmeraldRead about cold chain →
Mapping of the room
A study before commissioning, after changes and typically in both summer and winter.
Temperature mappingRead about temperature mapping →
Refrigeration plant and backup power
Compressors and UPS via dry contact or 4-20 mA, so technical faults also raise an alarm.
Universal Smart-SensorRead about third-party equipment →Compliance for pharma and hospitals, explained in plain English
The rules rarely say "buy a monitoring system". They say that conditions must be under control and documented. Here is what that means in practice.
GMP
Good Manufacturing Practice
Requires that the conditions affecting product quality are under control. In practice: round-the-clock measurement, an alarm on deviation and a log that can be presented.
Applies to production and QCGDP
Good Distribution Practice
Requires that medicines are stored and transported within their temperature window. Mapping documents that the whole room holds, not just the middle.
Applies to storage and transportEU GMP Annex 11
Computerised systems
Requires that the system is validated, that data cannot be changed without a trace, and that access is controlled. We carry out the validation, on our own or together with your QA.
Applies to the software itself21 CFR Part 11
Electronic records
US requirement for electronic signatures and audit trail. Relevant if you export to the USA or work for a US parent company.
Applies to exports to the USAWhere is the line between us and you?
We supply the system, the documentation and the validation itself: audit trail, traceable calibration certificates, timestamped readings and reports, and IQ, OQ and PQ carried out by us, on our own or in close cooperation with your QA. You define the scope based on your own risk assessment.
Validation: who does what →OCEAView from DICKSON, set up and maintained by us
The hardware is DICKSON's. The software is DICKSON's. Everything between the equipment and your day-to-day work is ours. And once the system is in place, it is yours. You buy it, you own it, and no leasing agreement decides when you can switch, expand or stop. We take care of maintenance so it keeps running.
OCEAView
The whole setup on one screen. Watch mode gives a combined status overview of the equipment you have access to, with up to 100 units per page, and every graph can be zoomed down to the individual minute. Plan View also places the points on your own floor plan, so the person on call can see which room it concerns.
An audit trail that cannot be altered
Every reading, alarm and acknowledgement with timestamp and user. That is what an auditor asks for.
Report in one click
Choose a period and export the report as PDF or CSV. Ready before anyone asks.
Cloud or your own servers
On-premises runs at your site with LDAP, and you control updates yourselves, so the qualification holds.
DICKSON
The manufacturer
Builds data loggers, sensors and OCEAView. French and American production, its own accredited calibration laboratories and CE, FCC and IC approved equipment.
Djurhuus IT
Distributor since 2018
We advise on placement, design the setup, install, set up alarms and on-call rotas, train your staff on the system and manage calibration afterwards.
You
Owner of the system
The system is yours. You set the limits, response times and requirements according to your own SOPs. We supply the system and the documentation, handle the validation, on our own or in close cooperation with you, and maintain it afterwards.
Frequently asked questions
Do we need to map the whole warehouse?
Yes, if you need to document that the whole room holds. A mapping study shows the distribution and points to where the fixed sensors should sit afterwards.
How many fixed sensors are needed?
That is decided by the mapping study and by the size and zones of the room. A small cold room needs only a few points, a large warehouse requires more.
Do we need to map in both summer and winter?
If the room is affected by the outdoor temperature, yes. The warmest point in winter is rarely the same as in summer.
Can we follow a shipment in transit?
Yes. An Emerald sensor in the box or trailer logs all the way and is read via phone on receipt. The readings go into the same system as everything else.
How do we avoid an alarm every time the loading door opens?
Each limit can have its own delay, and a dry contact cable on the loading door also shows whether an open door was the cause.
Who is responsible for the validation?
We are, on our own or in close cooperation with your QA. You define the scope based on your risk assessment, and we carry out IQ, OQ and PQ and deliver the documentation.
Other areas in pharma
Same system, different requirements. See how we monitor the rest of the chain.
Pharmaceutical production
Temperature, humidity and pressure in production areas, process equipment and intermediate storage.
Read more →Cold chain and transport
A sensor in the shipment, read on the phone on receipt.
Read more →
Mapping of storage and cold rooms
How we find the extreme points before the sensors are installed.
Read more →Kom hurtigt i kontakt med den rette specialist.
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