Every technology transfer is different and therefore needs a different solution. Some things, however, are the same from project to project. We asked our experts what the most important things are in a technology transfer project. Here’s our top 3 key factors to a successful site transfer.
Like in any project, open and direct communication is the foundation for a successful technology transfer. Schedule weekly or bi-weekly meetings with the transfer teams from both sites to ensure that open issues or sudden obstacles can be dealt with in a timely manner. Make sure that a clear timeline for the project is shared with both transfer teams – and kept up to date. In larger projects, smaller, more agile sub-teams with regular meetings might be useful to ensure that experts of each area in the receiving and sending sites can communicate together at a sufficiently detailed level.
2. Feasibility check
Are there differences in technical capabilities between the sites? Do the manufacturing processes, packaging materials or analytical methods have to be changed due to the transfer? Will the new site use different raw material suppliers? Is there a need to buy new equipment at the receiving site? Will there be changes to the logistics of the finished product which will require new transport studies? Evaluate the differences between the transferring and receiving sites early on in the project.
3. Strategic planning for already registered products
If differences between the transferring and receiving sites are found, evaluate the regulatory impact and plan the studies needed to support the possible changes either before, during or after the site transfer. Are you going to make improvements to your methods prior to the transfer at the current site and then transfer processes that are as identical as possible, or are you ready to justify the needed changes due to the (technical) differences between the sites? Is there a need to keep the current manufacturing site in the MAA during the transition period and propose the new site as an alternative site, or can you change the site at once? Strategic planning with clear prioritization and understanding of the regulatory requirements is an essential part of project management.
Do you need resources for your technology transfer project?
Medfiles’ experts have years of experience in sterile and non-sterile human and veterinary products as well as solid competence in consultancy services in regulatory and transfer strategies. With this expertise, we are here to help you by tailoring the best possible practical approach for your needs, specifying the studies needed to meet the regulatory requirements while always allocating resources in the most reasonable way.
Efficient project management
- We will help you manage your technology transfer tasks while ensuring regulatory compliance.
Strong CMC expertise and high-quality documentation
- You can trust us with the compilation of full quality documentation needed for a successful regulatory approval of your technology transfer.
- Besides regulatory documentation, our experts can help you by compiling the following documents:
- Analytical method transfer plans and reports
- Manufacturing process transfer plans and reports
- Validation protocols and reports
- ICH stability study protocols and reports
- Change control and risk assessments
- Our experts have a long working history in both analytical chemistry and manufacturing processes.
- Our resources come with guaranteed back-ups when it suits you best, for both short-term and long-term projects.
We are happy to help and tailor the best solution for your needs – contact us for more information!
Additionally, Medfiles’ Regulatory Affairs Team is also here to help by effectively managing submissions and the correspondence with the authorities for you.