Dr Michael Braun, Boehringer Ingelheim Pharma, Germany
Dr Andrea Staab, Boehringer Ingelheim Pharma, Germany
Dr Jobst Limberg, Federal Institute for Drugs and Medical Devices, BfArM, Germany
Dr Gerald Kindermann, F. Hoffmann-La Roche, Switzerland
The aim of this two-day course is to provide practical guidance on how QbD principles can be translated and implemented in drug product development. This course will deal among others with the following questions:
- What are the opportunities and challenges of applying QbD to drug product development?
- What are the current status and future expectations of QbD (ICH, FDA, EMA)?
- How can Quality Target Product Profile (QTPP) and concepts of life cycle management (ICH Q12) increase regulatory flexibility?
- What are the regulatory expectations in view of terminology and QbD related content of module 3?
- How to perform focused risk assessments for efficient development work?
- Why is it important to have a clear understanding and expectation of process performance?
- What is the impact of QbD on drug product development, scale-up and transfer?
- How can QbD also benefit marketed products?
Interactive workshops will enable delegates to apply what they have learned and to discuss the concepts in more detail. Delegates will have the opportunity to work through the whole QbD process by gaining “hands-on experience” from a number of examples and case studies.
The pharmaceutical industry is currently embracing QbD concepts to help improve the robustness of manufacturing processes and to facilitate continuous improvement strategies to enhance product quality and availability throughout a product’s life cycle. QbD ensures product quality and requires process performance characteristics to be scientifically designed to meet specific objectives, not merely empirically derived from the performance of test batches. Key QbD concepts are described in ICH guidelines Q8 Pharmaceutical Development, Q9 Quality Risk Management and Q10 Pharmaceutical Quality System. A new ICH guideline Q12 on Life cycle Management, which is intended to complement existing ICH Q8 to Q11 guidelines, is planned.
Risk- and science-based product development requires the support of structured tools for experimental planning and knowledge management. The documentation of the development work in risk assessments and development reports is a key to efficient compilation of the submission dossier.
Process Analytical Technology (PAT) is a key tool to an effective implementation of QbD as a way to achieve process knowledge and control. Through application of PAT during development and advanced monitoring and control options, process performance can be improved.
Initiatives from regulatory authorities like the recently published draft Annex 17 (EU GMP Guideline) on “Real Time Release Testing” emphasize the advances in the application of PAT, QbD and quality risk management (QRM) principles to pharmaceutical development and manufacturing (including quality control).
This course aims to provide a potential way how to meet current regulatory expectations and realize the Process Design Stage in practice. Special focus is set on the application of an alternate risk assessment approach as a guiding tool that drives drug product development. Another important aspect is adequate reporting and documentation of results that are finally summarized in the submission dossier.
This course is designed for drug product managers and scientists who are responsible for performing or reviewing activities like drug product development, process validation, scale-up and transfer, and CMC dossier preparation.
In addition, QA and regulatory affairs professionals will benefit from this course by gaining an understanding of current CMC trends. This will aid more effective multifunctional discussions on these topics within industry.
Introduction to drug product development – setting the scene
Expectations from regulatory agencies
- 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
- 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
Quality Risk Assessment and Control Strategy
- 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)
QbD Toolbox: Case studies DoE, PAT, and Basic Statistics
- 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
Reports and Documentation
- Value-added use of QbD tools – generic approaches and tailored solutions
- Case studies and examples for different unit operations and variable problems
Wrap-up & Final Discussion
- Development Reports
- Transfer protocols and reports
- Control Strategy and link to the submission dossier
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