Design of GMP/GEP Production Facilities
End-to-end efficiency, from manufacturing to market:
efficient and future-oriented.
Laura Mantyk
Compliance Specialist / Consultant
Efficient GMP Solutions for Life Science Production
The life science industry faces the challenge of meeting the highest regulatory requirements such as GMP, ISO 13485, or FDA QSR while remaining efficient and competitive. GRÜNEWALD supports pharmaceutical, biotech, and medical device companies in achieving exactly that.
We design and implement new GMP production lines, support qualification and validation projects, relocate existing facilities, and optimize processes across the entire value chain. Our integrated consulting approach combines regulatory expertise, Lean Management, and Quality by Design (QbD) to deliver robust, scalable, and audit-proof processes.
Our services include:
- GMP-compliant planning, implementation, and optimization of production processes
- Risk-based process control (e.g., IPC, final inspection) and efficiency enhancement
- Clear documentation and modular training concepts for employee qualification
With methods such as Design of Experiments (DoE), Value Stream Mapping, and the 5S method, we identify improvement potential, reduce complexity, and create structures that work in practice, not just on paper.
Planning New GMP Production Lines
When you plan a new production facility you set the course for tomorrow. A well planned flow of production steps is essential for efficiency, quality and scalability. We bring deep expertise in cGMP engineering and proven solutions from many client projects. Our Lean GMP approach builds in efficiency from the start and keeps space for future growth. Our goal is simple: concepts that work in daily operations and meet all regulatory requirements.
Lean GMP Documentation
GMP guidance is extensive, yet implementation can be clear and efficient. Together with our clients we create robust solutions that satisfy inspections and unlock efficiency. Our Lean GMP approach reduces effort, saves cost and keeps documentation easy to follow.
Hygiene Design and Qualification
Our cross functional team of engineers, biologists, chemists and biotechnologists supports hygiene planning in line with EN ISO 14644 and EU GMP. Using VDI 2083 we apply a risk based method: we identify critical sources of contamination and define clear acceptance and test criteria for cleanrooms, processes and products.
Personnel Qualification and GMP Training
Strong audit and inspection readiness means more than checking documents. We support with gap analysis, employee training, workshops, mock audits and coordination with authorities.
Testing Processes and Measurement System Analysis
With MSA projects we show that statistics are practical and can raise productivity. We start with an engaging workshop and create clear, actionable analyses that improve routine work from gauge capability to process optimisation.
Qualification and Validation
GMP Qualification
GMP qualification is a prerequisite for the use of production relevant systems. The scope and effort depend on system complexity and a risk based assessment.
Our compliance and risk experts rely on current GMP regulations and a solid lifecycle concept to implement your qualification projects efficiently.
With our Lean GMP consulting we help you save time and cost while keeping quality high and consistent.
GMP Facility Relocation
When relocating GMP facilities, safety and reusability come first. We analyse risks in advance with a structured relocation risk analysis.
This ensures that systems can be safely packaged, transported and commissioned again on site through functional testing, without full requalification.
The approach saves time and validation effort and clearly reduces the total cost of relocation.
Computer System Validation (CSV)
The validation of computerised systems is a core element of the digital GMP environment, especially in Industry 4.0.
GRÜNEWALD performs complete system assessment and requirements analysis, prepares validation plans and executes them efficiently.
Our Lean GMP CSV checklist enables structured processes, high result quality and real relief for your teams, in a secure and audit ready IT landscape.
End to end process optimisation and scaling
Our toolbox for end to end process optimisation in GMP production combines methods that, based on practical experience, deliver lasting efficiency gains and clear cost savings.
We go far beyond classic 5S and focus on solutions that work in daily operations on the shop floor.
Reducing downtime
Downtime is one of the strongest cost drivers in GMP production.
We identify concrete levers to cut downtime, for example maintenance during production, backup capacity or active service level management. Remote services and IoT solutions enable faster response and higher equipment availability.
Reducing complexity in GMP documentation
Lean and well structured documentation saves time and effort and raises implementation quality in practice.
Our specialists analyse processes with a neutral view and simplify documentation without reducing compliance. This lowers the effort for training, onboarding and inspections and supports continuous improvement from a documentation perspective.
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