Meet the Expert: Dr. Inga Schlösser on GMP and Quality Consulting at Exyte

Good Manufacturing Practice (GMP) Consulting: Quality from design to validation

 

Dr. Inga Schlösser leads the Good Manufacturing Practice (GMP) & Quality Consulting team at Exyte and ensures that GMP requirements are integrated seamlessly throughout the project life cycle.

 

GMP consulting is a key component of pharmaceutical facility planning. GMP refers to a set of guidelines and regulations that ensure products are consistently produced and controlled according to quality standards. In the life science industry, its importance is increasing as companies deal with digitalization and evolving regulatory requirements. GMP consultants play a cross-functional role across all project stages as the quality of medicines manufactured by our customers significantly depends on the design of facilities and manufacturing process equipment. Therefore, qualification activities are an integral part of GMP consultants’ responsibilities. 

 

 

“Right the first time” approach paves the way for project success

 

Therefore, the GMP consulting team of Exyte follows the "right the first time" approach: Thinking ahead and incorporating compliance considerations from early on are essential to the team’s work. 

From the very start of a project, they collaborate with all stakeholders and suppliers to help identify potential challenges and develop practical solutions before timelines or compliance are impacted. “Commissioning & Qualification (C&Q) begins in the mind,” says Schlösser. Already in the conceptual design phase (CD) a GMP process risk assessment lays the foundation for subsequent steps. These include developing clear User Requirement Specifications (URS), evaluating critical process risks, and translating them into a compliant facility layout and equipment design.  

As the project progresses into the Detail Design (DD) phase, key activities are design reviews, updates to the GMP risk assessment, and design qualification. In the final C&Q phase, all relevant quality requirements are verified during Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PG). "We aim for resource-oriented planning that remains viable until the entire project is completed," explains Schlösser.  
Microbiology Microscope

From microbiology to GMP consulting

Schlösser’s path into pharmaceutical GMP consulting and planning began in microbiology. After earning her master’s degree in food technology, Schlösser pursued a PhD in food microbiology, where she gained initial insights into quality management in highly regulated industries. During her PhD, she worked in a laboratory where she implemented a quality management system and gained experience in risk assessments and process optimization – skills that later formed the foundation for her work in GMP consulting. 

Her interest in the practical application of quality standards as well as her desire to work people-driven led her to her role. Around five years ago, she joined Pharmaplan, initially working on projects as a GMP expert. Within a year, she began leading a GMP consulting team. 

Long-lasting people empowerment

 

Beyond her technical responsibilities, Schlösser sees her role primarily in supporting her team members in their professional growth. Her team consists of specialists who continuously expand their expertise through mastering new challenges. "It's not just about technical solutions; it’s about the people,” she explains. “I see it as my responsibility to support my team and give them the opportunity to grow beyond what they thought was possible."  

This philosophy also applies to customer relationships at Exyte. Especially in GMP consulting, continuous customer support and interdisciplinary knowledge transfer play a critical role. Long-term collaboration ensures that regulatory requirements are viewed within the context of operational processes. "Especially in a time when companies and markets are constantly evolving, our continuous support provides security," says Schlösser. 

Digitalized biopharma facility

Digitalization and lean GMP

In addition to established methods, digital solutions and lean GMP approaches are gaining importance. The transition to electronic documentation and digitized qualification processes offers new opportunities to make qualifications more efficient and transparent. "Our goal is to optimize processes so they can meet the growing demands of the industry," says Schlösser. “My personal mission is to guide the customer in such a way that a smooth qualification leads to a successful project and ultimately to a safe drug for the patients.” 

Need support with GMP compliance or qualification planning? 


Get in touch with our GMP Consulting team to discuss how we can support your project from design to delivery. 
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