Validation and Qualification for Compliance
Validation is necessary to confirm that in-transit storage chambers produce the expected results. GxP rules require that all processes undergo validation, including facilities that intend to adhere to cold chain compliance standards.
On the other hand, qualification looks at proving that a system, transport box, or organization satisfies a particular purpose.
Transportation of pharmaceuticals requires special tools and facilities. The vehicles need extra protective features to shelter products from temperature fluctuations and other weather elements.
ELPRO monitoring systems are ideal to monitor the temperature and other parameters in transport containers, from the product's collection point to the destination.
With continuous feedback from such systems, one can conduct validation and qualification procedures effectively. Without adherence to GDP transport guidelines, it is like walking in pitch darkness; there is nothing to show cold chain compliance for transportation chambers, storage facilities, and equipment.
It is crucial to qualify all elements before validation can begin. Some essential pharmaceutical distribution chain components that need qualification and validation are storage chambers, insulated boxes, data loggers, and cold rooms.
Once these components undergo qualification as stipulated in the EU-GMP Guideline Annex 15, then validation can begin. It is impossible to have GDP compliance without validation and qualification programs in place.