Day 1
Introduction
- The validation life cycle
Process Validation Life Cycle, Regulatory Requirements
- Setting the scene for Process Validation
- Introduction to EMA’s PV guides, Annex 15, and to FDA’s PV guide
- Regulatory requirements
Process Design
- Process Design
- Quality by Design, ICH Q8 and Q11
- Quality Target Product Profile
- Critical Quality Attribute
- Critical Process Parameter
- Design Space
- Control Strategy
- Continual Improvement
- Link between QbD the Control Strategy and Process Design
Systems and Tools for gaining Process
- Understanding and establishing the Control Strategy
- Process Understanding & the Control Strategy
- Quality Risk Management
- Process Analytical Technology
- Design of Experiments
- Process Analysers
- Multivariate Data Analysis
Q&A
Case Study Process Design
- Stage 1
- Applying QbD principles to design a process for an oral solid dosage formulation
- Examples of the application of DoE and PAT
- Establishing the control strategy
Process Validation / Process Performance Qualification
- The purpose and principles of PV/PPQ
- EU’s different approaches to Process Validation
- Number of PV/PPQ batches
- Acceptance criteria
- PV/PPQ readiness
- PV/PPQ reporting and conclusion
Case Study Process Validation / Process Performance Qualification
- Stage 2.1: Designing the equipment and facility qualification programme based on the control strategy
- Stage 2.2: Establishing the PPQ/PV programme based oin the control strategy
- Justifying the number of PPQ/PV batches
- Presenting and evaluating data
- Concluding the PPQ/PV activities
- Proposing a stage 3 CPV/OPV programme
Q&A
Day 2
Ongoing/Continued Process Verification
- EMA: Ongoing Process Verification
- FDA: Continued Process Verification
- Statistical tools
- Monitoring plan – OPV/CPV plan
- OPV/CPV for legacy products
Case Study Ongoing/Continued Process Verification
- Establishing the CPV/OPV programme
- Application of relevant statistics during stage 3
Case Study Ongoing Process Verification Programme for Legacy Products
- Establishing an OPV programme for legacy products
- Defining the relevant statistical metrics
- Running, evaluating and updating the programme
Wrap-up and considerations for Process Validation in a future Industry 4.0 manufacturing environment
- How will process validation evolve in light of more automated and self-optimising processes
- A holistic approach to validation – covering qualification of equipment, control systems, computer systems, processes and analytical technologies and methods
- The role of the control strategy
Q&A