Line Lundsberg-Nielsen

Subject matter expert - GMP and compliance

"Having a clear focus on the patient, the end-user of our products, should really be the key driver for the way we develop and manufacture things in the future."

Line is a Global Technology Partner in GMP and Regulatory aspects. She has worked in the pharmaceutical industry, both in pharmaceutical development and product manufacturing, for the last 20 years. Her background is in physics and she holds a PhD in Process Analytical Technology.

Line’s main consulting areas include: regulatory expectations, future pharma trends in smart manufacturing & control, Quality by Design (QbD), process analytical technology (PAT) including real time release testing, process validation, and good manufacturing principles combined with science and risk-based innovative development and manufacturing.

Line is experienced in pharmaceutical development using a science and risk-based QbD approach. She has worked with different innovator and generic clients implementing QbD strategies, QbD programmes, QbD tools, advanced control strategies based on real time release and QbD-based regulatory submissions of new product applications (MAA). She has also been part of a team developing, submitting and gaining approval for an oral solid dosage formulation based on QbD, design space, PAT and full real-time-release testing.

Line was one of the pioneers that, together with the FDA, EMA and the ASTM standard organisation, helped to develop the Science and Risk-based framework - the new foundation for product development and manufacturing in the pharmaceutical and biotech industry. She is active in ISPE, a member of the global PAT & Lifecycle Control Strategy Community of Practice, a global trainer in QbD and process validation, advisor for De Montfort University and their QbD programme, and a well-recognised speaker at international conferences and events.

What's your view on the industry?

"It is all about focusing on the patient when we develop and manufacture medicines. That sounds obvious, but has unfortunately not always been the case. Having a clear focus on the patient, the end-user of our products, should really be the key driver for the way we develop and manufacture products in the future.

Understanding what is really critical to the patient in terms of safety and efficacy enables us to formulate a product with the right performance characteristics. It also enables us to design related manufacturing processes which can consistently deliver as expected. With this enhanced understanding, we can minimise any potential risks to the quality of the product by controlling what is critical during processing. Moreover, we can ensure that products are always manufactured with the right quality profile. This benefits not only the patient but also the business because processes are more robust and quality is designed into the products right from the beginning.”

Why do you work in this business?

"I have always wanted to work in an industry that focuses on improving quality of life, and have been working in the pharmaceutical industry since my PhD days. I have mainly held innovative responsibilities, e.g. in connection with implementation of process analytical technology (PAT) for gaining process understanding or for controlling manufacturing processes. I have applied Quality by Design (QbD) principles to develop new products and optimise already marketed products. Additionally, I have helped customers to apply a science and risk-based approach to the way they validate processes throughout the life of their products"

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Expert in

  • Quality by Design
  • Regulatory submissions based on applying enhanced QbD approach
  • QbD for Legacy Products
  • Equipment Qualification based on Science & Risk-Based Verification
  • Process Validation
  • Process Analytical Technology
  • Quality Risk Management & Risk Assessment
  • Pharmaceutical Quality System
  • Pharmaceutical Manufacturing, Late Stage Development & Scale-up
  • NIR Spectroscopy & Characterisation
  • Real Time Release Testing (RTRT) & Design Space Applications
  • Manufacturing Excellence

Recording: Manage the challenges of pharma 4.0

Control strategy is hot right now - it's a requirement, and it's good business. It is also a focus point for the FDA, issuing 5 warning letters in August and September alone. Get up to speed on control strategy with this webinar.

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