AHU VALIDATION IN PHARMA PDF

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. We carry out a qualification study to prove that the particular asset is good enough to store the medicine.

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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. We carry out a qualification study to prove that the particular asset is good enough to store the medicine.

What is validation? A process involves multiple steps possible involving multiple assets as well. It can be for a process within the same asset as well. Temperature validation of delivery process of a medicine. Validation is for a method or process such as complete delivery of a medicine. 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. In the process, all the assets used for delivery such as the box, the van etc. 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. 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. Related Articles on qualification and validation:.

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Read More.. The average airflow velocity is calculated by dividing the total of the airflow grid velocities by the number of readings taken. These are offered for both the Pharmaceutical and Microelectronics industries. Testing and evaluating filters minimum once annually and potentiality twice annually is required for optimum performance. Proper documentation and certification is provided by us and this also helps predict potential performance issues and increases filter life. Our Particle Count Test provides complete airborne particle count cleanliness classification. The test is performed to determine the actual particle count level within the facility at the time of the test.

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What is difference between Qualification and validation in cold chain?

Define the measuring plane perpendicular to the supply air flow and divide va,idation measuring plane into grid cells of equal area. These are performed to validate whether AHU is working accurately as per standard operating procedure. The distribution of smoke is observed. Photometer detects the leak of every 2 seconds. Join Log In 8.

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