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
Transfer to a CMO
- 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
Analytic Transfer – Organisation & Scheduling
- Pre-requisites when considering an analytical method transfer
- Dealing with non-validated methods
- Why analytical methods should be transferred first ?
- Is training of “receiving” analysts to be performed at “sending” site ?
- Using ICH Q2 as a support for the transfer of an analytical method
- Comparison of results : what are acceptable criteria ?
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?
- 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
Workshop: Development of a Transfer Plan
In the workshop you will apply what you have learned. You can choose between a sterile or a non-sterile product and develop a Transfer Plan according to the information and requirements you will get. This will include sourcing of the materials, the validation plan, training at the new site, and risk assessment and action planning.