Projects in the field of Technology Transfer, or TOT (Transfer of Technology), concern the transfer of knowledge and information. Examples of this are the transfer of a recently developed production process from the R&D organization to the production organization, the outsourcing of analyzes to a contract laboratory and the transfer of the production of medicines to another production site. The transfer of knowledge and information can be necessary if an organization needs additional production capacity, if there are cost considerations, compliance issues or, for example, an entire relocation of a production site to another country.

How can Progress help you with this?

Progress has often proven itself as a dependable, conscientious, and expert partner in the field of technology transfer. We have completed projects of varying sizes and can help your organization define the knowledge and information to be transferred and assist in implementing the transfer in accordance with guidelines such as: Annex 7 WHO guidelines on transfer of technology in pharmaceutical manufacturing. We prepare the technology transfer at both the receiving and transmitting locations. The project team should therefore preferably consist of representatives from both locations from the start. Together they make clear and explicit agreements about the scope of the transfer, the required documentation, the milestones, and the results. It must also be clear what requirements the receiving location must meet and any problems that still need to be resolved.

Complete documentation transfer

A good and complete documentation transfer is essential for a successful transition. Progress guarantees the availability of approved master production specifications and records, as well as packaging, cleaning, and logistic records. Together with the client, we determine the validation requirements at the receiving location. These are based on risk analysis and depend on the extent of the technology transfer. For example, validation can demonstrate the consistency and robustness of the transferred activities. It is important to continuously consider what influence a change in location may have on a validated process or analysis method and to adjust the validations accordingly. Where technology transfer occurs after initial clinical trial GMP manufacturing has been performed, it may be required to show comparability between the batch produced at the sending production site and the receiving production site. In practice, this means executing production runs with extensive analytical testing methods that demonstrate comparability. We have extensive experience with defining and executing comparability programs and  Process Validation.

The following aspects are important for a successful transfer:

• stability survey
• transport and storage conditions
• supplier changes
• influence of technology transfer on stock management
• changes in registration
• staff training
• relocation of equipment
• completion of activities at the deployment location