Process validation of manufacturing processes – Dossier requirements in the EU
- Relevant guidance documents
- Finished product process validation
- Traditional and enhanced approaches
- Process validation schemes
- Standard vs. non-standard processes
Traditional Process Validation and Continuous Process Verification
- What are the opportunities and challenges?
- What are the key aspects for the CTD?
- What should you consider for selecting the right validation strategy?
- What should you know about design space?
- What are typical validation questions to be addressed?
How to provide stability data in regulatory submissions
- Stability data from drug substances and drug products in the CTD
- Long term and accelerated conditions, in-use stability
- Requirements for the different climatic zones
- Stability summary and conclusion
- Process parameters with potential impact on drug substance/drug product stability
- Changes in the process: what has to be considered regarding stability?
Manufacture of active substances – Process validation and GMP issues
- API manufacture – What needs to be documented in the dossier?
- Process validation for APIs – Key aspects
- GMP for APIs
Case Studies on typical Validation Projects
- Standard and non-standard processes
- Validation approach for drug substances and drug products
- Validation strategy and planning from development to registration
- Specific points to be considered for EU and US
Basic requirements and expectations of the FDA regarding process validation
- Approach to and considerations for process validation
- Process Design
- Process qualification and process performance qualification (PPQ)
- The PPQ protocol – execution and report
Handling Post-Approval Changes in manufacturing processes
- Which GMP and regulatory aspects need to be considered (e.g. site/process changes)?
- How to define the validation strategy?
- What are the challenges?
- How to be successful?
Process validation for the manufacture of biotech-derived APIs – process evaluation and verification
- Process evaluation
- Critical quality attributes (CQAs) of the active substance
- Small scale models
- Process verification studies and data
- Number of batches to be presented
- Design space option
- Evaluation of the upstream process
- Criticality assignment of process parameters
- Potential impact of raw materials
- Verification of upstream process
- Single use equipment
- Evaluation and verification of downstream process
- Comparability of products manufactured in different sites