Bringing a new product or drug onto the market, outsourcing your production or relocating your location of production: this takes a lot of effort and time and any delay might result in loss of income. An efficient transfer of technologies between all parties involved can speed up this kind of processes. It lays the foundations for your further production process, control strategy, process validation and continuous improvement initiatives. QbD has developed a Lean Technology Transfer Framework that supports your tech transfer process more efficiently and rapidly.
Our Technology Transfer Framework as lingua franca
The scenarios mentioned above all involve a transfer of documented technical expertise and processes between a sending and receiving unit. This data exchange is absolutely crucial, as it forms the basis for all the development and production activities involved in bringing a product onto the market. However, very few companies have policies or a standardised approach in place to ensure adequate transfer of technologies between departments, companies or locations. The QbD Lean Technology Transfer Framework consists of a scenario, risk-based approach combined with templates. It serves as a lingua franca and ensures thorough understanding between both the sending and receiving units during your tech transfer.
Tech transfer services
A tech transfer process involves a lengthy list of action points and checks. By focusing on the right 20 percent, you already have 80 percent of your project on track. Reap the benefits of our Technology Transfer Framework. It offers strong support in ensuring legal compliance, helps you set the right priorities and avoid pitfalls, and allows your transfer process to proceed much more efficiently and rapidly. Our experts are ready to provide advice on data exchange, validation, registration and more. They are familiar with the processes on both the sending and receiving side, with the complex regulations and with the quality challenges facing your industry. We also support you during the implementation of the transfer process, which consists of four phases:
- Phase 1. Duties and responsibilities
- Phase 2. Data exchange
- Phase 3. Testing and process validation
- Phase 4. Registration dossier and lessons learnt