QbD for Drug Products: Background and Practical Aspects
- Essentials to know about QbD
- Steps for defining QTPP/CQA/CPP
- Benefits of the QbD Approach
- Practical Examples
QbD - Regulatory Perspective
- Current state of PAT & QbD implementation and regulatory challenges
- Quality by on-line (PAT) measurements
- Real time release testing: general considerations
- Going forward: ICH Q12 / Q13 / Q14
Interactive Sessions: QBD for Drug Products
- QTPP – CQA – CPP for different kinds of formulations, e.g. Oral formulations (Tablets, vs. Biotech vs. Vaccines)
- Typical points of discussions within teams
Development of the Drug Substance (Focus on Biotech)
- Strategies to consider for development
- Key points and potential pitfalls
- Ways to success for the submission of the dossier
- Typical questions from regulators
Development and launch of a QbD process (Drug Product)
- Lab and pilot phase investigations for criticality assessments and design space definition
- Verification of the design space and the RTRT methods at full scale
- Post approval activities and the use of a post approval change management protocol
From the design board to the implementation in the manufacturing plant: Practical examples of PAT in small and large molecules
- PAT Toolbox
- PAT as an enabler of Process Understanding and Quality Assurance
- Main milestones in the implementation of PAT for RTRT: Example in small molecules
- The big opportunities lurking around: Examples of development of PAT solutions for large molecules
Case examples: Control strategy options for a QbD process
- Case example for solid dosage form process with Real Time Release Testing (RTRT) enabled by PAT and a Design Space approach
- Case example for an small molecule API manufacturing process with PAT and SPC (Statistical Process Control) elements
- The PAT toolbox for pharmaceutical manufacturing and launches
DoE examples for API development
- DoE theory:
- Resolution and confounding
- Overview of available DoE designs
- Basic statistics – understanding my software analysis
- Intuitive interpretation of the design: mapping
- Practical approach to DoE aimed to reduce the number of experiments:
- Risk assessment: Fishbone (Ishikawa) diagram; FMEA (failure Mode Effect Analysis) and RPN analysis (Risk Priority Number)
- Choosing the design
- Practical tips for execution
Continuous Process Verification and lifecycle approach of a QbD process
- Differences to the traditional validation approach
- Case example of an NDA using the alternative validation approach
- Draft ICH Q12: Life cycle management of a QbD process in the framework of ongoing process verification