Top advice regarding qualification and validation

Top advice regarding qualification and validation

With Rommelag Pharma Service, we offer those who purchase a bottelpack system a quick and economical complete concept for qualification and validation, which is recognized by the authorities. We know what matters and can perform the entire process more cost-effectively, successfully, and reliably than you. It is, of course, entirely up to you as to whether we should only assist you in an advisory capacity, take on full project management, handle the entire validation service for you, or simply provide you with the blank documents.. 

You can also make use of Rommelag Pharma Service for systems which have already been installed and are already operational. The experience we have gathered at our production facilities puts us in a position to offer you comprehensive advice on efficient system usage and on optimizing the entire production process.

Our experts will offer advice and plan your entire project together with you, from the greenfield stage to the complete production processes. We recommend that you incorporate Rommelag Pharma Service early on – it will be worth your while.

Everything you need for the validation of your bottelpack system

We will discuss all the risks with you and will put together a risk analysis document.

Definition and selection of all the necessary system components, to ensure that your product can be manufactured in accordance with your specifications and the GMP/FDA guidelines.

Our service team sees to it that your system is set up and installed correctly. We also make sure the machine documentation contains all the relevant information.

Once your system has been set up, we check all of its primary functions together with you. This gives us the opportunity to set the key parameters and to keep fine-tuning the system at your premises until everything is to your complete satisfaction.

We perform multiple tests under real conditions, all the way up to the system’s critical load, checking that all the system’s functions and components are in perfect working order. Once testing has been successfully completed, nothing stands in the way of process validation, and you can then begin to earn money with your new system.

If further tests and qualification are needed during the validation of your system, we will happily handle these for you, too. Additionally, the data collected in the factory acceptance test (FAT) can be used for qualification and validation documentation as part of our fast-track concept.


Your contact for Qualification and Validation

Rommelag Pharma Service