With the publication of ICH Q2(R2) and ICH Q14, the modern Quality by Design (QbD) paradigm introduced by ICH Q8 for manufacturing has now been extended to Quality Control (QC). A life cycle and risk-based management approach are encouraged, integrating quality directly into analytical techniques.
This concept, known as Analytical Quality by Design (AQbD), requires a comprehensive understanding of all aspects of analytical procedures to enhance confidence in reportable values, improve reliability, and ensure product quality—ultimately safeguarding patient safety.
This new, improved framework promotes living and dynamic processes while also calling for modern techniques and technologies. Nuclear Magnetic Resonance (NMR) is entirely compatible with these new notions.
NMR, which is based on universal and absolute principles, can greatly simplify risk assessment and analytical procedure management.
It benefits from a broad method operable design region and is one of the few technologies that can leverage the new notion of platform procedures, allowing for the testing of quality attributes of several items without requiring significant procedure adjustments. Furthermore, the inherent reasons of technology make qualifying and monitoring simpler.
This webinar will explore the advantages of using compact, cryogen-free benchtop NMR for AQbD-oriented quality control in both qualitative and quantitative applications.
The session will demonstrate the development of rapid yet straightforward NMR techniques for identification—one of the most commonly performed tests. Additionally, the benefits of quantitative NMR (qNMR) for simplifying QC assay process development will be highlighted through case studies on model medicinal products.
The webinar will also cover the application of standard compendial testing and discuss options for fully GMP-compliant testing, which is essential for successfully integrating benchtop NMR technology into quality control laboratories.
Key learning topics
- The benefits of using NMR for quality control analytical operations
- The implementation of NMR technology in QC laboratories with compact, cryogen-free benchtop spectrometers
- An introduction to GMP compliance solutions for benchtop NMR procedures.
About the speakers
Valentin Poirier holds a Ph.D. in chemistry from the University of Rennes, specializing in organometallic catalysis and polymers. He later transitioned into the pharmaceutical industry, focusing on analytical techniques, particularly NMR and MS.
Over the past decade, he has led NMR and MS analytical platforms at CROs, contributing to numerous pharmaceutical and quality control projects with a customer-centric, problem-solving approach.
In 2024, Poirier joined Bruker BioSpin as a Solution Product Manager for the Pharma Team, where he collaborates with the pharmaceutical industry to advance NMR solutions for Quality Control, Compliance, and CRO/CDMO applications.
Fabrice Moriaud, Ph.D., is the Product Manager at GxP Solutions. As a Solutions Development Manager at Bruker BioSpin, he has extensive experience in developing solutions for the pharmaceutical industry.
With a strong background in chemistry, Fabrice has significant academic expertise in EPR and NMR, contributing to advancements in analytical technologies.