ICH Q14 Analytical Procedure Development
Key Learning Outcomes
- Understand the objectives and development history of ICH Q14, from its inception in 2018 through to Step 4 in 2023, and how it harmonises scientific and risk-based approaches to analytical procedure development in line with ICH Q8, Q9, Q12, and Q2.
- Learn the difference between minimal and enhanced approaches to analytical procedure development, and how implementing more elements of the enhanced approach fosters deeper procedural understanding, increased lifecycle flexibility, and more suitable established conditions.
- Discover how the Analytical Target Profile (ATP) serves as the central, technology-independent performance framework connecting CQA (Critical Quality Attribute) control requirements to analytical procedure development, validation, and ongoing lifecycle management.
- Explore how established conditions and reporting categories are identified and justified through risk assessment, prior knowledge, and development data, and how the ICHQ14 framework links procedural change risk to the appropriate regulatory pathway.
Event Overview
This session offers an authoritative, expert-led overview of ICH Q14, the ICH guideline on analytical procedure development, from the perspective of a member of the Expert Working Group that drafted it. The presentation covers not only the content of the guideline but also the regulatory intent behind it, giving participants a uniquely informed view on how the framework is meant to be applied in practice.
The session begins with the development history of ICH Q14, outlining the journey from the 2018 concept paper through two rounds of stakeholder review, public consultation, and over 3,000 comments addressed before reaching Step 4 in November 2023. This background helps clarify key design choices in the guideline, including the decision to regard the minimal approach as a fully acceptable baseline, with the enhanced approach serving as a spectrum of increasing understanding rather than a binary requirement.
The core concepts of the guideline are then systematically unpacked. The Analytical Target Profile is presented as the future, technology-independent framework that converts CQA control requirements, derived from the QTPP, patient exposure considerations, and existing regulations, into analytical performance requirements. The session describes how the ATP guides technology selection, informs development studies, and underpins validation and lifecycle management throughout the procedure’s duration.
Risk assessment is examined thoroughly, detailing how ICH Q9 tools such as Ishikawa diagrams and preliminary hazard analysis are employed to identify and prioritise analytical procedure parameters, guide the design of development studies, and influence the procedure control strategy, including established acceptable ranges and the method operable design region. The session subsequently discusses established conditions and reporting categories, which are among the most practically important aspects of ICH Q14, illustrating how risk assessment, development data, and predefined performance criteria work together to determine whether a change needs prior approval, notification, or requires no regulatory reporting.
A detailed cell-based potency assay case study from Annex 1 of ICH Q14 illustrates these concepts, guiding through the lifecycle change management plan, the risk categorisation of individual established conditions, and an example of a change from cultured cells to ready-to-use cells. It shows how a medium-risk change can be downgraded to notification-low through documented risk mitigation.
Who Should Attend?
Anyone involved in developing, validating, or submitting regulatory documents related to analytical procedures who seeks to understand the purpose, framework, and real-world application of ICH Q14 from an expert point of view.
- Analytical Scientists and Method Development Chemists
- Validation and Compliance Scientists
- Regulatory Affairs and CMC Submission Specialists
- Quality Control and Quality Assurance Professionals
- Biopharmaceutical and Small Molecule Development Teams
- Lifecycle Management and Change Control Specialists
- R&D and Technical Operations Managers overseeing analytical functions
Unlock Additional Educational Resources
Register today for Christof’s 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. Christof Finkler Senior Director, CMC Policy - Technical DevelopmentSenior Director, CMC Policy - Technical Development BiotechF. Hoffmann-La Roche AG (Switzerland)Dr. Christof Finkler is the Senior Director of CMC Policy within Technical Development Biotech at Roche and also acts as a senior technical advisor within Roche’s biotech development. In his previous role as Site Head of Analytical Development and Quality Control Biochemistry at Roche’s headquarters in Basel, Switzerland, he was responsible for establishing new analytical technologies, protein characterisation, and the development and validation of analytical methods, as well as the quality control of investigational medicinal products and the transfer of analytics to the commercial QC units. In addition to his extensive knowledge in the field of analytics, Christof is an expert in QbD for product and process development and has led Roche’s QbD initiative. Christof serves as the EFPIA topic lead for analytical lifecycle management and is a member of the ICHQ2/Q14 expert working group/implementation working group and the EFPIA ICHQ1/Q5C support team. He is also a member of the CASSS Board of Directors, serves as a board member of the IQ Consortium, and is part of the board of the Analytical Science division of the Swiss Chemical Society.
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