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Testo Industrial Services employees in a clean room

PRACTICE-ORIENTED AND MANUFACTURER-INDEPENDENT SUPPORT

Risk-based qualification.

SERVICES

Risk-based qualification

We qualify clean rooms, plants & utilities, transport & storage in accordance with GMP and with great expertise

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.

Our service for you:

  • Support from individual measurements to project management
  • Conception and consulting for risk-based planning and qualification of cleanrooms, systems and utilities, equipment, transport systems and storage areas
  • Qualification support across all qualification phases - DQ, IQ, OQ and PQ
  • Development of risk management and implementation of risk analysis
  • Preparation of the qualification documents and reports
  • Performance of all qualification tests and measurements
  • Complete coordination of your project
  • Training of your employees in practice-oriented seminars and workshops
  • We share our practice-oriented expert knowledge and know-how with you

Our qualification services in detail

GMP Compliance

Explanations and definitions of the qualification

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:

  • Design qualification (DQ, Design Qualification),  
  • Installation Qualification (IQ),  
  • Operational Qualification (OQ) and
  • Performance Qualification (PQ).


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.

References of our GMP projects

MORE REFERENCES

Customer's vote

"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

More service, more security for your GMP compliance

What sets us apart

Expertise

Consulting, measurements, project management – our team with experience of the industry will support you precisely according to your needs

Technology

The use of our extensive test and measuring equipment with over 4,500 references ensures reliable measurement and test results

Documentation

We will hand over the documentation to you in person upon completion of the order in audit-proven layout or customised to requirements

Your contact

Please call us at:

Fon: +44 1420 544433

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