QbD in Drug Product Devbelopment AND QbD in API Manufacturing

Programme

Quality by Design in Drug Product Development

Introduction to drug product development – setting the scene

• Drug product development at a glance – from first in man to marketing authorization
• Pharmaceutical QbD: Quo vadis?
• Application of QbD principles to drug product development

Expectations from regulatory agencies

• Regulatory initiatives and approaches for supporting emerging technologies
• Concepts of Real Time Release Testing (Draft Annex 17 EU GMP Guideline)
• Harmonization of regulatory requirements (QbD parallel-assessment FDA-EMA, ICH Q8 -> Draft Q12?)
• Regulatory expectations: Lessons learned from applications so far

Knowledge Management

• Knowledge Management (KM) System - Definition and Reason
• Knowledge Management Cycle
• Explicit and Tacit Knowledge - The Knowledge Spiral
• Correlation between KM and other Processes
• Enabling Knowledge Management
• Knowledge Review - integral part of the Management Review (ICH Q10)

Quality Risk Assessment and Control Strategy

• Objectives of Quality Risk Assessment (QRA) as part of development
• Overview to risk assessment tools
• Introduction of Process Risk Map
• Introduction of risk based control strategy development

QbD Toolbox: Case studies DoE, PAT, and Basic Statistics

• Value-added use of QbD tools – generic approaches and tailored solutions
• Case studies and examples for different unit operations and variable problems

Reports and Documentation

• Development Reports
• Transfer protocols and reports
• Control Strategy and link to the submission dossier

Wrap-up & Final Discussion
The concepts and tools used over the two days will be summarized and future implications and opportunities of applying QbD principles to process development will be discussed. Delegates will be given time to ask questions on how they can apply what they have learned to their own drug product development and manufacturing.

Workshop Process Risk Map & link to Control Strategy
Based on a risk assessment tool tailored to cover development needs, delegates will work on case studies of process development for a solid oral dosage form.
From QTPP and CQA to relationship analysis of process parameters and material attributes
Process mapping for integrated documentation of the development work
Process Risk Map as a tool for development-focussed risk assessment

Quality by Design in API Manufacturing

General framework and key elements of QbD for APIs – background and potential strategies

• What is it all about?
• What are the benefits?
• When and how should you use it?
• Practical examples with typical points of discussion

How to identify and control Critical Quality Attributes (CQAs) in API synthesis – a risk-based approach to developing a control strategy

• Severity assessment of quality attributes
• Impact levels for critical process parameters (CPPs) and critical material attributes (CMAs)
• Considerations for the API Starting material
• Design of an effective risk-based control strategy
• Examples

How to provide information on the development of the API manufacturing process – dossier requirements

• What should be done at which stage?
• Which information is relevant for the dossier?
• What are the key-points to be considered for APIs (NCE/Biotech) and their formulations
• Typical questions from Authorities

Process Evaluation and Design Space

• Changing Validation Approach
• Validation Life Cycle
• Design Space Concept

Application of PAT in the API industry

• PAT at development stages of a QbD-based development
• PAT as part of the Control Strategy in a GMP environment
• Practical examples of PAT implementations at a commercial scale in a GMP environmen

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Control strategies – Case studies and examples

• HA definitions
• Why and When is a control strategy needed
• Different types/elements of a control strategy
• Practical examples

Workshop Identification and classification of CQAs in API synthesis
In this workshop delegates will elaborate criticality analyses of different APIs. As part of this analyses critical quality attributes and critical process steps within the synthesis of the APIs will be identified.