Quality is the basis of Life Science. With our GMP services, from GMP compliance consulting to qualification and validation, we have created the prerequisites for this.

We have been implementing projects for the Life Sciences industry for more than three decades. GMP sets the pace in all this. We know the relevant regulations, the challenges of hygiene, premises, equipment, documentation and controls.

Interdisciplinary teams
We bring together a wide range of skills in one team and deliver an efficient, closely coordinated solution geared to the specific processes. 
Identifying requirements
Interpreting all requirements correctly and implementing them on time, while remaining pragmatic, will get you safely to your goal.
The global GMP regulatory environment is undergoing constant change. Our experts will help you identify and apply the relevant industry standards.

With our experience in GMP compliance, qualification and validation, we bring new buildings, rooms and upgrades safely to conclusion.

GMP Consulting
With our end-to-end approach, we’ll support your GMP projects from the initial analysis to successful operational approval. This is an interdisciplinary challenge in which we bring together all the stakeholders: architects, engineers, pharmacists, construction project managers and qualifiers.

On the one hand, trade in medicinal products (drugs and medical devices) is subject to numerous and detailed regulations, and on the other hand, it is sometimes difficult to distinguish them from food supplements, cosmetics or consumer products. In order to get an initial overview, it is imperative that one should get GMP consultation.
Qualification means putting the sample to the test - i.e. to demonstrate through testing that a system, a technical device or a plant has been designed in accordance with GMP guidelines, works perfectly and actually leads to the expected results.

This requires GMP-compliant construction (design) - Design Qualification (DQ), installation or set-up according to plan - Installation Qualification (IQ), proof of functionality that meets all operational requirements - Operational Qualification (OQ) and demonstration of overall performance that meets the requirements - Performance Qualification (PQ).

Along this cascade, we do our utmost to implement the relevant GMP regulations safely and pragmatically. 
To ensure that your products will always meet the quality requirements, we’ll validate your processes and systems according to the relevant GMP regulations. For this purpose, a documented validation programme must be available to the authorities. This should serve to prove that an effective and reproducable product that meets the predefined specifications and quality characteristics can be manufactured, when the established parameters are met. 

Furthermore, quality risk management is now essential to proactively identify potential quality risks, scientifically assess and control them, and continuously improve processes. The results will not only please the supervisory authorities, but will also pay off economically for you.

Cleanroom Systems 

Magnus Willers


Magnus Willers

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