Fundamentals of Technology Transfer
- Various types of transfer
- Regulation and GMP challenges for Technology Transfer
- Identifying key elements of Technology Transfer
- What to consider when planning a Technology Transfer
- How to set acceptance criteria for a successful transfer
Product Transfer from a CMO Management Perspective
- Why to conduct tech transfers to a CMO?
- Facts and Figures
- Dos and Don’ts - What to consider when working with a CMO?
- How to apply the “One Face to the Customer”-Concept in complex tech transfer situations?
Technological Aspects: Non-Sterile Transfers
- Identifying materials involved
- Defining the process, equipment and facility requirements
- Defining validation requirements
- Product hand over and completion of oral dose transfer
Sterile Manufacturing Site Change - Process Characteristics
- Comparison of equipment and clean rooms / barrier systems of sending and receiving unit
- Critical quality parameters of product and process
- How to establish comparability criteria
- What is fixed and what can be changed: packaging material, process parameters, equipment, ... (?)
- Frequent failures & trouble shooting
Case Study Ferring: Transfer of an (aseptic lyophilized) US product between European sites
- Scope of the Site Change
- Project Plan, Project Phases and Timelines
- Documentation of the transfer
- Regulatory Strategy (US)
- Unforeseen gaps
- Project Reporting
Developing a regulatory strategy for a site change
- Regulatory Guidance documents
- Differences EU, US, RoW
- Classification of transfers from a regulatory point of view
- Data & documents needed
- Timelines & costs
Handling changes during a process transfer
After having set up a regulatory strategy for a site change, most often further process and technology changes occur and become necessary for continuing with the transfer project.
- How to deal with this unplanned changes?
- Classification of changes
- How do this changes alter the overall strategy?
Project Management
- Setting up the project and the Transfer team
- Project Plan and Transfer Mater Plan: how to document the transfer activities
- Monitoring of the transfer activities
- Definition of milestones and time management
- Pre-evaluation and feasibility phase, preparatory phase, project completion phase
GMP-compliant Documentation & Finalisation
- Defining documentation required pre & post transfer
- Roles and responsibilities of parties in preparation, review and approval of documentation
- Reporting of transfer findings and change control
- How to manage the transition period (e.g. first few batches!)
- Document check list