GMP

Trust is the basis of Life Science. With our GMP qualification, 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.
Reduce-to-the-maximum 
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
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.

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. 
Validation
To ensure that your products will always meet the quality requirements, we’ll validate your processes and systems according to the current GMP regulations. For this purpose, a documented validation programme must be available to the authorities and this should serve to prove the effectiveness and stability of the processes.

In addition, there is need these days to continuously improve risk management and the associated recurring observations of the processes. The results will not only please the supervisory authorities, but will also be of economic benefit to you.
LIFE SCIENCES
HEALTHCARE

Cleanroom Systems 

Perry Fischer

GMP Leader

Perry Fischer

GMP Leader
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