Course No 15153
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Dr Rango Dietrich, PharmDev Innovations
Dr Jochen Felix Kepert, Roche Diagnostics
Dr Rainer Lang, Roche Diagnostics
Dr Line Lundsberg-Nielsen, NNE Pharmaplan
You will be updated on the latest regulatory developments and learn how to apply the respective paradigms in Pharmaceutical Development to be better able to design strategies for the implementation of “quality by design” according to ICH Q8(R2) and ICH Q11.
In workshops, you will discuss elements and methodologies associated with ICH Q8(R2) and ICH Q11. All this will be illustrated with examples and case studies.
The impact of ICH Q8(R2), Q9, Q10, and Q11 is changing both the regulatory expectations and the strategies of Pharmaceutical Development, and this impact will continue to grow, especially in view of the emerging ICH Q12 Guideline.
The “quality by design” concept described in ICH Q8(R2) and ICH Q11 have to be seen as an overarching paradigm and an interdisciplinary approach across the product lifecycle. It also systematically emphasises enhanced product and process understanding throughout the product lifecycle.
Ideally, application of ICH Q8(R2) and Q11 elements already starts in the early design phase of a drug product where both patient needs and process design are considered. The “quality by design concept” requires a comprehensive understanding of the chemical and physical nature of the individual active substance(s) and excipients, and of the way their attributes interact in the formulation and with the manufacturing process. During the design phase, it is important to determine the Critical Quality Attributes (CQAs), identify Critical Process Parameters (CPPs) and Critical Material Attributes (CMAs) and to understand how the process parameters and material attributes affect the CQAs. The relationship between process inputs (material attributes and process parameters) and the CQAs is described in the Design Space and ensured during manufacturing with an enhanced control strategy, leading to greater operational flexibility with reduced regulatory filing requirements.
ICH Q8(R2) will open the door to a powerful era of refined, modern and efficient Pharmaceutical Development for those companies who are ready to invest in this new paradigm.
This training course is designed for all scientists, engineers, managers and executives from Pharmaceutical and Biotech Development units, including Quality Assurance and Technical/CMC Regulatory Affairs, who are involved in the implementation of ICH Q8 elements.
How ICH Q8(R2), Q9, Q10 & Q11 Guidelines work together from Development to Product Realisation
Expectations from the guidelines and the enablers
Product Life-Cycle Management
Are concepts and methodologies really new?
Redesigning current approaches to match future regulatory demands
Key Concepts of QbD and how they all link together
Quality Target Profile (QTPP)
Critical Quality Attributes (CQAs) and Critical Process parameters (CPPs)
The role of Material Attributes
QTTP – CQA – CPP
DoE - Design Space
Design Space: from early Development to Process Validation
Define: Target setting as pre-requisite for a design space:
Quality Target Product Profile QTPP
Do: Methodologies (DoE) and how to apply
Evaluate: How to interpret and apply a design space
Maintain: Product Life-Cycle Management
Conclude: How to lead the way for successful process validation
Forget: The 3-batches paradigm
How the enhanced Control Strategy links back to the QTPP and leads to
effective controls of CPPs and ensures the CQAs meet their Specifications.
Traditional versus enhanced Control Strategy
The link between QTPP, CQAs, CPPs, Design Space and Enhanced
Implementation of the Control Strategy into Manufacturing
Link between Control Strategy and Batch Release Strategy
Post-approval lifecycle management
Identification of CQAs for a Biotech Product & Establishment of an Enhanced Control Strategy that ensures the CQAs meet their Specifications (Biotech).
The link between QTPP, CQAs, CPPs, Design Space and Enhanced Control Strategy
How to apply PAT during Pharmaceutical Development
What is PAT and how is PAT related to QbD
Introduction to PAT tools: Process Analysers, Design of Experiments,
Multivariate Data Analysis, Process Control, Knowledge Management
and Continual Improvement
Examples of PAT applications during development
QbD as a Life Cycle Approach: from Development to Process Validation
and Continuous Process Verification
(Examples from both small molecules and biotech)
Real life: Blending validation using DoE and Design Space
Post-approval lifecycle management plan for a biotech product