Warehouse Temperature Monitoring System: Installation, Qualification & Calibration in Detail
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.