Commissioning and qualification of production equipment

Commissioning is the process where we thoroughly check, test, and confirm that production equipment meets specific standards and performance criteria. Our engineers are experts in this process, carefully examining equipment functionality, validating control systems, and verifying operational parameters. This detailed approach helps to reduce potential risks and ensures that key assets are ready for operation.

Alongside this, Qualification is the essential practice of proving that production equipment and systems perform as expected. Our engineers are skilled in managing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. These protocols involve a complete evaluation of equipment integrity and process performance, including the validation of crucial utility systems, to ensure they meet the strict criteria set by regulatory bodies.

Moreover, our specialists are fully aware of the current regulatory frameworks and standards that govern Commissioning and Qualification processes, including the current Good Manufacturing Practice (cGMP) guidelines. They stay updated with changes in regulatory standards, ensuring that our clients always comply with the latest requirements.
In addition to these skills, our engineers have practical experience in carrying out Commissioning and Qualification tasks across a wide range of pharmaceutical facilities. This includes both traditional pharmaceutical manufacturing processes and new technologies in medical device production, ensuring a comprehensive and adaptable approach to compliance.

In conclusion, our consultancy offers unmatched expertise in Commissioning and Qualification processes, backed by the exceptional skills of our engineers. We enable pharmaceutical manufacturers and medical device developers to navigate regulatory compliance accurately and effectively, leading to the production of top-quality therapeutics and medical devices.

We strive to implement simple and operational solutions, and can support the implementation of procedures and training activities that ensure compliance with existing authority requirements and inspection readiness.

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Commissioning and qualification of production equipment cases

Commissioning and qualification of production equipment profiles

Chemical knowledge
Innovation and technology management
Project and portfolio management
Risk analysis and barrier creation
Stakeholder management
Unit operations
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Chris Hammerum

Finished Products Engineering Consultant
Documentation
Innovation methods
Personal
Project Management and Organizational skills
Technology
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Silla Eva Bertelsen

Finished Products Engineering Consultant
Through 5 years at university, internship and professional work, Mikhail has acquired a wide range of competences from different projects at the university and industry.
Analyzing and optimizing processes for production lines
Data analysis
Development of concepts
Problem solving for production lines
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Mikhail Vladimirovich Prokopiev

Finished Products Engineering Consultant
Nermin has a wide range of competencies related to Project Management, GMP, Process Optimization, Automation and Quality Management through his time at DTU and professional work. Based on previous experience, he is a service-minded individual that prioritize the needs and satisfaction of customers in his work and strive to provide high-quality solutions.
Data Driven
Personal
Technology
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Nermin Fejzic

Finished Products Engineering Consultant
With customer service and an understanding of manufacturing, Linus systematically finds the solution between man and technology. His open mindset and stakeholder management are used to create maintain and evolve relations. Relations he used technological knowledge to create SOP, which lifts quality and is intuitive.
GMP
Personal
Project management
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Linus Knoop

Finished Products Engineering Consultant
Torben has +20 years of experience in the pharmaceutical industry with focus on project management and validation of several inspection and assembly lines as well as packaging lines for the Packaging of Finished Goods.
Performing commissioning/validation tests.
Project management
Writing commissioning/validation documentation
Writing URS
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Torben Jensen

Specialist and senior project manager
Filip has acquired knowledge of general theoretical knowledge within the life-science industry as a hard-working student and student assistant for several years. He has further developed an interest and flair for the use and understanding of pharmaceutical industrial tools, where he has been through several independent and team-based projects
GMP
Personal
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Filip Novovic

Finished Products Engineering Consultant
Per has a wide range of competences acquired through more than 20 years of experience from Pharma and life science projects though his work for a variety of national and international bio-tech/life science /pharmaceutical/medical device companies both early stage (new products) and late stage (mature products).
GMP
Personal
Project management
Technology
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Per Rønsholt Andresen

Co-founder, specialist, senior project manager & chairman of the boards
Palle has more than 13 years of experience within automation engineering of machinery in life science projects.
Automation strategies
GMP
L-AUS
Technology
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Palle Jørgin

Senior consultant, Automation engineering
Martin has through his studies and professional work acquired a wide range of competences and knowledge within user-centred design, project management, digitalization, sustainability and a variation of different product development processes.
Communication
Design Thinking
Product Development
Project management
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Martin Muncanovic

Finished Products Engineering Consultant
Since 1996 Klaus has been working with many aspects regarding special designed assembly and packaging equipment within pharmaceutical and medical device production.
QMS Systems
Validation of packaging and assembly equipment
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Klaus Kildebæk Rasmussen

Senior Consultant
Helene is a passionate engineer with competencies within project management, documentation, and Good Manufacturing Practice (GMP). She has worked on projects spanning from sterile production and assay design to protocol optimization and chemical analysis.
 Good Manufacturing Practice
Personal
Project management
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Helene Cecilie Kiilerich Frederiksen

Finished Products Engineering Consultant
Bo has more than 25 years of experience in the pharmaceutical and medical device industry. Bo has spent the years working as designer, consultant and project manager in projects concerning medical devices and drug delivery systems.
Management Consulting
Mechanical Engineering/Design
Project management
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Bo Hejgaard Pedersen

Co-founder, specialist and senior project manager

Co-founder / Managing Partner in Finished Products Engineering

Bo Hejgaard Pedersen

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