The words qualification and validation are used interchangeably in the cold chain industry especially pharma industry. However, there are slight differences between the two. We are trying to explain the difference in this article.
What is a qualification of an asset used in pharma?
Basically, temperature qualification is on equipment or assets used to store medicines, vaccines etc. This involves temperature mapping study, design qualification, performance qualification, operation qualification etc. Please see our detailed page on Temperature qualification study for more details. We carry out a qualification study to prove that the particular asset is good enough to store the medicine.
Eg. Temperature qualification is applicable for assets such as a medicine cold room to certify that it is good for storing the medicines between 2 to 8°C under all operational conditions within the cold room.
What is validation?
The validation is done for methods and processes. A process involves multiple steps possible involving multiple assets as well. It can be for a process within the same asset as well. Please see few example below for better understanding.
- Temperature validation of delivery process of a medicine.
Validation is for a method or process such as complete delivery of a medicine. Eg. If you want to validate the process of a medicine distribution, you have to start the complete testing process from the moment of packing from the cold room, moving it through your warehouse, loading it onto a van, van travels to a particular destination for certain hours, a person carries it to the customer etc. This validates that your entire process is good and the medicine is not affected. If a temperature validation is done for this process, it means that the method you tested is good enough to keep the quality of the medicines.
In the process, all the assets used for delivery such as the box, the van etc. have to be qualified as well.
- Validation of despatch process of a medicine through air
Suppose you regularly despatch medicine through the air to another country. This involves a lot of movement of the goods through various procedures. From your warehouse onwards it changes many hands, many temperature conditions, many types of vehicles etc. You need to make sure that the medicine you despatch from your warehouse reaches in good condition at another country. You might be trying to validate despatch through different flight routes. Once you validate, you will see the best selection.
- Validation of a software for a monitoring system
Validation is also applicable for software of a monitoring system to prove that the software is delivering the data correctly. In the case of a monitoring system, there are many components starting from a sensor, and different software and hardware interfaces. All of them have to work perfectly until the report reaches you. This is software validation. Otherwise, you have no guarantee that what the display unit shows in the cold room is same as that you see in the software. It is possible that there will be errors since the data is passing through entirely different platforms. For validation of electronic measuring instruments, there is a standard issued by the Federal Government of the USA. The relevant standards for such monitoring system are 21 CFR Part 11. Please read more on 21 CFR Part 11 at this page.
- Validation of packing method inside a cold room
Suppose you want to unpack a big box of medicines and repack in smaller packages for distribution. This involves opening the big box, counting each item, making smaller packs on a working table etc. This is a method involving multiple processes. You will have to validate this process to ensure that the medicine is not affected.
Conclusion: What is difference between Temperature qualification and validation
The above examples might have given you a good idea regarding the difference. We will conclude that a qualification process is only for a particular asset such as a cold room, warehouse, van, reefer, cold box etc. A validation involves certification of a set of processes when a parameter passes through different environments.