August 11,2023

What is the difference between qualification certification and validation in the cold chain-

Household Dehumidifier_221 Series The terms' qualification 'and' validation 'can be used interchangeably in the cold chain industry, especially in the pharmaceutical industry. However, there are subtle differences between the two. We attempt to explain the differences in this article What are the qualifications for assets used in pharmaceuticals Basically, temperature identification is a device or asset used to store drugs, vaccines, etc. This involves temperature mapping research, design qualifications, performance qualifications, operational qualifications, etc. For detailed information, please refer to our temperature identification research details page. We conduct qualification studies to demonstrate that specific assets are sufficient to store drugs. For example. The temperature limit applies to assets such as pharmaceutical refrigeration rooms to demonstrate that drugs are stored between 2 and 8 ° C under all operating conditions in the refrigeration room

What is validation Validation is done for methods and processes. The process involves multiple steps that may involve multiple assets. It can also be used for processes within the same asset. Please refer to the following examples for a better understanding

Temperature verification of drug delivery process Validation is aimed at a method or process, such as complete delivery of drugs. For example. If you want to verify the process of drug distribution, you must start the complete testing process from the moment of packaging in the refrigerated room, move it through your warehouse, load it onto a truck, travel to a specific destination for hours, and bring it to customers by one person. This proves that your entire process is good and the medication is not affected. If temperature validation is performed on this process, it indicates that the method you tested is sufficient to maintain the quality of the drug During this process, all assets used for delivery, such as boxes, trucks, etc., must also be qualified

Verify the delivery process of drugs through air

The temperature limit of refrigerated trucks assumes that you frequently send drugs to another country through air.

. This involves a large amount of cargo movement through various programs. Starting from your warehouse, it will change many hands, many temperature conditions, many types of vehicles, etc. You need to ensure that the medication shipped from the warehouse is in good condition in other countries/regions. You may be trying to confirm shipment through different routes. After verification, you will see the best choice

Verify the software of the monitoring system

Verification also applies to the software of the monitoring system to prove that the software correctly provides data.

. In the case of monitoring systems, there are many components that start with sensors, as well as different software and hardware interfaces. All of these must work perfectly until the report is given to you. This is software validation. Otherwise, you cannot guarantee that the content displayed by the display unit in the refrigeration room is the same as what you see in the software. Due to data passing through completely different platforms, errors may occur. There is a standard issued by the government for the verification of electronic measuring instruments

Verify the packaging method in the refrigerated room

Temperature identification of the medicine box. Assuming you want to open a large box of medicine and repackage it with smaller packaging for distribution.

. This includes opening the large box, calculating each item, and making smaller packaging on the workbench. This is a method that involves multiple processes. You must verify this process to ensure that the medication is not affected

Conclusion: What are the differences between temperature identification and validation

The above examples may give you an understanding of the differences.

. We will conclude that the qualification process is only applicable to specific assets, such as refrigerators, warehouses, trucks, Cooler, Cooler, etc. Validation involves authenticating a set of processes when parameters pass through different environments