Monica Hueg has more than 17 years of experience with construction and verification/qualification/validation of biotech, pharmaceuticals and medical device facilities and their related production.
Monica focuses on facilitating strategic business decisions with special attention to quality, compliance and lean qualification such as implementing ASTM E2500. She consults on strategic planning for future production and quality improvements, often in connection with compliance gap analysis/assessments.
Monica has a master's degree in social science from Roskilde University, Denmark, and extensive theoretical insight and practical experience within GMP and compliance. She is involved in the analysis, planning, implementation and completion of a wide range of projects within the pharma industry globally.
Monica regularly teaches courses within GMP and compliance and she has developed a number of courses within the topic.
What's your view on the industry?
"In my view, one of the most interesting trends right now is the science-and-risk-driven approach. I believe that understanding and managing risks are crucial for turning front-end investment decisions into sound manufacturing and operations. Understanding what is critical to the patient in terms of the safety and efficacy of the medicinal product enables us to formulate the product with the right performance characteristics. With a thorough understanding – based on scientific data – of the products and processes, you can set up the right control strategy to control what is critical during processing. This allows us to minimise any potential risks to the products' quality, improve the use of resources, and release the product to market in a faster and more reliable way.
"With a thorough understanding – based on science data – of the products and processes, you can set up the right control strategies to control what is critical during the processing.”
The concept of building quality into the product from the beginning is not only beneficial for the patient. It is also sound business. Processes are more robust, and thus the yields are higher. Quality by Design, combined with an emphasis on ongoing/continued process verification based on updated process knowledge, improves the pharmaceutical industry’s ability to implement changes and optimise processes on an ongoing basis.
When switching to more innovative solutions, significant emphasis has to be placed on staying compliant. Being in compliance is a prerequisite for being in business – the license to operate.”
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