Qualification & Support for GMP-compliance
We support you in your qualification projects such as cleanroom qualification or plant qualification. We also qualify your warehouses and transport systems according to GDP and GSP standards.
Alongside validation, risk-based qualification is a central element of quality assurance in GxP-regulated industries, such as the pharmaceutical industry or medical technology. From the qualification of individual devices to the qualification and validation of complex plants, GMP upgrades or new construction projects in the compliance area, Testo Industrial Services offers you the necessary manpower, the know-how and the appropriate measurement technology individually and according to your needs.
Our qualification service: Ensuring high quality in a GMP-compliant manner
Risk-based qualification is the documented proof that a facility/room is suitable for the intended purpose and complies with regulations and standards. Quality risk management (QRM) can be used to control and monitor all measures for controlling quality risks.
With our qualification services, we support you individually and according to your needs with expertise, measurement technology and documentation. We would be happy to give you a detailed insight into risk-based qualification. Arrange a presentation appointment with our qualification experts today.
Our service for you:
- Support from individual measurements to project management
- Design and consulting for risk-based planning and qualification of cleanrooms, plants and utilities, equipment as well as transport systems and storage areas
- Qualification support across all qualification phases - DQ, IQ, OQ and PQ
- Establishment of risk management and implementation of risk analyses
- Preparation of the qualification documents and reports
- Carrying out all qualification tests and measurements
- Complete coordination of your project
- Training your employees in practical seminars and workshops
- We share our practice-oriented expert knowledge and know-how with you
Cleanroom qualification
Safety and compliance for your cleanrooms
Qualification of plants & utilities
Ensures process stability and robustness
Transport and storage qualification
GxP services for storage areas, packaging and transport systems
Medical Technology Services
Safety and compliance in medical technology
We also implement your quality assurance measures in the areas of calibration, qualification, validation and compliance in a pragmatic, cost-sensitive and effective manner in the medical technology environment.
Your advantage: Our competence
- Expertise: Consulting, measurements, project management - our industry-experienced team supports you precisely & in line with your needs
- Technology: The use of our measuring equipment with more than 4,500 references ensures reliable measurement and test results.
- Documentation: We hand over the documentation in the audit-proven layout or individually according to customer requirements to you personally on completion of the order.
Risk management
In order to ensure the overarching goal of patient safety, potential defects and hazards to product quality must be identified and controlled. This requires the establishment of a comprehensive process of risk assessment, control and monitoring throughout the product life cycle. We have been involved in risk analysis and risk management for many years and know your requirements exactly. Our industry experienced GxP-Services Team supports you in identifying weak points and risks as well as in defining control measures and implementing them in the course of qualification and validation.
This is how we support you in your quality risk management:
- Structuring and planning of compliance activities for sound risk management according to ICH Q9/EU-GMP Part III
- Integration of all project participants in the risk management process
- Structuring, preparation and moderation of risk analyses according to established methods (e.g. FMEA)
- Advice & support for the implementation of a risk management strategy
GxP-Services Team
Professional competence, experience and high-precision equipment. The engineers and technicians of our GxP-Services Team are on duty for you throughout Europe. Take advantage of the professional expertise of our engineers and technicians! Arrange a non-binding consultation appointment for your qualification project today:
GxP services made to measure
More service, more security for your GxP compliance. Convince yourself of our full-service offer and the know-how for your requirements:
Opens video in overlayThe setting of Youtube cookies is blocked until an active click on the play button is made. With this click, you give your consent for Youtube to set cookies on the terminal device you are using. You can find more information on our data protection page.Success stories
We support you in your projects and are committed to your goals. Here you will find an excerpt from the references of our successful GMP projects.
Losan Pharma GmbH
Full service support: cleanroom qualification and calibration
Paul Hartmann AG
New clean room construction: Project support & qualification
Grünenthal GmbH
Solids production: Qualification of a tablet line
Testo Industrial Services brings both the necessary metrological and regulatory know-how as well as a lived customer orientation, so that we have already relied on this support in the area of qualification and calibration for over 10 years. Thanks to the permanent deployment of experts from Testo Industrial Services at Losan in Neuchâtel, we enjoy the highest level of security with regard to compliance requirements with low coordination efforts and transparent processes.
Magdalena Zakowski
Head of Equipment Management
Losan Pharma GmbH
