Analytical Quality by Design: Analytical Procedure Control Strategy (ACPS)
Key Learning Outcomes
- Understand what the Analytical Procedure Control Strategy (APCS) is, how ICH guidelines define it, and why “fit for purpose,” not simply “valid,” is the correct standard against which analytical procedures should be evaluated.
- Learn how the APCS connects each stage of method development, from the Analytical Target Profile through technology selection, parameter optimisation, and validation, into a coherent, purpose-driven control framework.
- Discover how risk assessment tools, including FMEA-style scoring of impact, probability, and detectability, can systematically identify failure modes and prioritise the controls and experiments needed to address them.
- Explore the practical levers available to strengthen an APCS: reducing failure probability through robust parameters and standardised procedures, and improving detectability through system suitability controls, bracketing, trending, and assay monitoring.
Event Overview
This session by Dr Lars Geurink discusses one of the most common and problematic attitudes in analytical science: the tendency to expand system suitability criteria when assays fail, instead of addressing the core performance issue. Using the ICH Q14 framework as its foundation, the presentation offers a clear and comprehensive overview of what the Analytical Procedure Control Strategy genuinely involves, includes, and how to intentionally establish it.
The session begins by clarifying definitions: the APCS as a set of controls based on current understanding to ensure suitability throughout the analytical lifecycle, and system suitability testing as an within-assay measurement set, not a pass/fail gate to be adjusted when results are inconvenient. A comprehensive process flow then maps how the Analytical Target Profile (ATP), understanding and selecting technology, development findings, and validation evidence all connect to form a dynamic control strategy.
To make these concepts tangible, the presentation walks through a detailed ELISA incubation example, applying risk scoring across time and temperature parameters to show how failure modes are identified, ranked, and progressively mitigated, from initial feasibility experiments through DoE optimisation, QC transfer, and procedural controls. The result is a practical, step-by-step demonstration of how an APCS evolves alongside method understanding.
The session concludes with a reframing of the initial challenge: assays that do not pass system suitability are not a criteria issue, but rather a method quality concern. A well-designed APCS highlights this early, supporting better decisions and ultimately leading to safer medicines.
Who Should Attend?
Anyone responsible for developing, transferring, validating, or executing analytical procedures who aims to create more robust and reliable control strategies based on the ICH Q14 enhanced approach.
- Analytical Scientists and Method Development Chemists
- Quality Control and Quality Assurance Professionals
- Regulatory Affairs and CMC Submission Specialists
- Biopharmaceutical and Small Molecule Development Teams
- Validation and Compliance Scientists
- R&D and Technical Operations Managers overseeing analytical functions
Unlock Additional Educational Resources
Register today for Lars’ presentation and gain access to exclusive bonus content, such as the insightful panel discussions on “Overview of the ICH Q14 Guideline” and “Key Challenges and Solutions in Implementing ICH Q14”.
Dr. Lars GeurinkAssociate Director Assay DevelopmentBatavia Biosciences (Netherlands)Dr. Lars Geurink is the Associate Director of Assay Development at Batavia Biosciences. Intrigued by biotechnology, immunology, and neuroscience, as well as being passionate about developing biotech products, Lars studied life sciences and technology at Universiteit Leiden and Technische Universiteit Delft. He earned his PhD from Uppsala Universitet, focusing on analytical quality by design (AQbD) for vaccine characterisation. Prior to joining Batavia Biosciences, Lars worked at Janssen Vaccines, where he served as team manager for analytical development and gained experience in analytical strategies for vaccine testing and implemented AQbD and provided analytical solutions for a new RNA vaccine platform. As Technical Lead at Batavia Biosciences, Lars deepened his expertise in biotech products, processes, and the biopharmaceutical lifecycle.
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