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In the pharmaceutical industry numerous and stringent regulations exist to ensure the efficacy of medications throughout the entire supply chain. A significant part of these regulations require adherence to GDP and GMP guidelines.


And to do this, you need to have a temperature monitoring system due to the sensitive nature of pharmaceutical products. Below we will explore the various validation, qualification, installation, and calibration processes and guidelines.





To understand qualification, it is important to first understand validation, as they go hand in hand. According to the GDP and GMP guidelines, validation ensures that any activity or process has the expected results.


In other words, validation is simply taking a closer inspection of a process that has already been completed. Validation happens in two steps.


Step one is defining what the expected results are, while step two is verifying and documenting that it is indeed true and that the process delivered the results that were expected.


For example, if you want to store pharmaceutical products in a warehouse, first you need to acquire the warehouse itself, hire new employees that are qualified to handle the various tasks that they are assigned to, get other equipment that will make sure the pharmaceutical products remain in the state they should be in, among other processes.


All the above components need to be validated during the validation process to ensure the expected results remain consistent. What this means is, validation can only take place if all the components in the warehouse are qualified to handle their various tasks from the start.


60904bb2e92f7_2_1 GMP Warehouse Guide

GMP Warehouse Guide for Compliant Temperature Monitoring in the Warehouse


Warehouse storage and distribution is a major area of concern when it comes to GMPs. Since most pharmaceuticals and industrial chemicals are shipped all over the world in bulk, most of them spend significant time in storage and in transit. Learn more today.





Qualification, on the other hand, is the process of proving that the components like the rooms, facility, the supplier, or transportation indeed perform the task they were meant to do in the best manner.


What this means is that if a component or equipment is used to handle, produce, transport, or store pharmaceutical products, the qualification process must be performed to demonstrate that the equipment is indeed working and is fit for the purpose it was intended.


A good example is if a warehouse temperature monitoring system should monitor the temperature between 2˚ and 8˚ in each area, the qualification should certify that the warehouse is indeed capable of doing so and that the desired temperature of 2˚ and 8˚ is maintained consistently.


This means that qualification starts typically by defining the purpose and then progresses to evaluating and documenting if the equipment is fit to do the job.



Temperature Mapping and Installation


Before installing a warehouse temperature monitoring system, it is imperative to carry out temperature mapping. Temperature mapping involves the study, documentation, and measurement of the distribution of temperature within an enclosure by finding the coldest and hottest parts.


The World Health Organization states that mapping can also be used to recognize the zones that require some remedial action. An excellent example of this is eliminating cold and hot spots by changing the existing air distribution.


Before a warehouse monitoring system is installed, temperature mapping usually takes a defined period of time, lasting between a few days to weeks. This is to monitor the temperature of the various parts inside the warehouse that form the grid pattern.


There are two principles that grid mapping follows.

  • The first principle states that a mapping grid should have a 3-D network of the mapping points with consistent intervals on the x, y, and z axes. The World Health Organization is the body that states the distances between the different points of mapping of the warehouse monitoring system.
  • The second principle states that the additional mapping points are the places that you expect the cold and hot spots. This could be a wall, seal, door, or an air outlet.

By following the floor or mapping plan, the mapping temperature data loggers that have already been calibrated and labeled are then placed at the different mapping points.


After a specific time period has passed and the mapping data loggers have been collected, the findings are then analyzed, and an overlaying of the measurement curves is completed.


Finally, the coldest and hottest points in the room can be identified before the warehouse temperature monitoring system is installed.


Temperature mapping is considered to be successful if the findings conclude that there have been no temperatures recorded outside the temperature range that is required.


Installation of the sensors in the warehouse temperature monitoring system should be done at the coldest and hottest points. It is crucial to define these spots to ensure that the warehouse monitoring system has a sensor placed in these spots to immediately trigger an alarm if the temperature is out of range.



Calibration of Sensors


Factory Calibration

Factory calibration, which sometimes can be referred to just as calibration, is a documented, reproducible process of comparing a traceable reference with the device that is being tested.


A reference device is usually an instrument with a very high degree of precision that is regularly checked. Calibration of sensors is generally done at several or just one measurement point.


In order for calibration of sensors to be used in a warehouse monitoring system is done, a stable environment should first be created. During the data logger calibration process, a calibration block or bath is used to keep the constant temperature, allowing both the devices to adjust to a certain temperature point.


For humidity calibration, a reference solution, which could be saltwater or a humidity generator, is used. A certain humidity level at a specific temperature is then generated for a given amount of time, and the two devices are then left to adjust to the relative humidity.


In both cases, after the process is completed, the values are then compared. The calibration certificate which holds the results can only be issued if the results are within the specification.


In-Process Calibration

This is a cheaper, less reliable, and faster way to calibrate as compared to factory calibration. This type of calibration is mainly used on temperature sensors and doesn’t involve the use of a calibration block or bath. This means that calibration is done by reading the values on the reference device and comparing them to the device you wish to calibrate.


In both cases, however, the reference device is a device of high precision that is regularly checked in a laboratory that has been accredited.


As the name suggests, this process is only done at one measuring point: the current process temperature.




An appropriate temperature monitoring system encompasses the aforementioned processes and follows the defined guidelines. ELPRO provides the perfect solution of a secure and reliable temperature monitoring system, dedicated to 100% compliance for pharmaceutical products.

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