ICH Q8 Training Course - From QbD to Process Validation

9-10 June 2015

Copenhagen, Denmark

Course No 9059

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Speakers

Dr Rango Dietrich, PharmDev Innovations
Dr Jochen Felix Kepert, Roche Diagnostics
Dr Rainer Lang, Roche Diagnostics
Dr Line Lundsberg-Nielsen, NNE Pharmaplan

Objectives

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 ICH Q8 and Quality by Design.

In workshops, you will discuss elements and methodologies associated with ICH Q8. All this will be illustrated with examples and case studies.

Background

The impact of ICH Q8, Q9 and Q10 is changing both the regulatory expectations and the strategies of Pharmaceutical Development, and this impact will continue to grow.

ICH Q8 and Quality by Design 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 elements already starts in the early design phase of a drug product where both patient needs and process design are considered. 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 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.

Target Group

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.

Programme

How ICH Q8, Q9 & Q10 Guidelines work together from Development to Product Realisation
Expectations from the guidelines and the enablers
Product Life-Cycle Quality 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
Design Space
Control Strategy
Continuous Improvement

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 Quality 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 Control Strategy
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
Lessons learned

Workshop Sessions
QTTP – CQA – CPP
DoE - Design Space
Control Strategy

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