In addition to validation, risk-based qualification is a central element of quality assurance in GxP-regulated industries, such as the pharmaceutical industry or medical engineering. Quality risk management (QRM) is used to manage and control all measures for controlling quality risks.
Testo Industrial Services supports you in your qualification projects such as clean room qualification or plant qualification. We also qualify your storage and transport systems according to GDP and GSP standards (Good Storage Practices and Good Distribution Practices). From the qualification of individual devices to the qualification and validation of complex systems, GMP upgrades or new construction projects in the compliance area, we offer you the necessary manpower, know-how and the appropriate measurement technology in line with your needs.
Efficacy, identity and purity are quality requirements that are placed on products from the GMP-regulated environment. The term GMP ("Good Manufacturing Practice") is used to summarise the quality assurance requirements of national and international regulations and laws such as the EU GMP guidelines, AMG and AMWHV. They primarily concern the production of drugs (pharmaceutical industry) and related products in the fields of medical technology and life sciences.
The qualification is part of the GMP requirements. It is the documented proof that a device/plant is suitable for the intended purpose and fulfils the specified functions. Qualification also proves that the products produced permanently comply with the regulations and standards - in other words, that they are GMP-compliant. The specific requirements for qualification and validation are defined in the EU GMP guidelines Annex 15.
Elements of a GMP qualification:
In the qualification master plan, the individual qualification objects are defined and the qualification steps are determined and planned. The master plan is a superordinate document that reflects the qualification strategy and the organizational structure in general.
All qualification steps are backed up by documentation that is fundamental for audits by the authorities and indispensable for obtaining a manufacturer's license. Following a qualification, a validation is carried out, for example, for manufacturing, transport or cleaning processes. Analytical methods or computer and software systems are also validated.
"Testo Industrial Services has the necessary metrological and regulatory know-how as well as an active customer orientation, so that we have been relying on this support in the area of qualification and calibration for over 10 years."
Magdalena Zakowski, Head of Equipment Management at Losan Pharma