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GxP Qualification

Machines and Plant Qualification

In the medical technology and pharmaceutical industry, the execution of a system qualification is an elementary part of the quality management system and a prerequisite for obtaining and maintaining the manufacturing permit

The qualification is an integral part of the GMP requirements and an essential milestone for further validation work. It is the documented evidence that a technical system is properly designed and installed according to the customer’s requirements and that it works exactly as it was originally designed by the plant/ machine operator.

A qualification also proves that the products produced permanently meet the regulations and standards – also they are GMP compliant. The specific requirements for qualification and validation are defined in the EU GMP guideline part 15.

Logix Automation GmbH supports its customers in the area of ​​qualification (GAMP 5 oriented) of machines and plants amongst other things with:

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