QbD whitepaper: Technology Transfer Needs a Lingua Franca20/06/2013 - Bart Van Acker, Founder/Managing Director at Quality by Design
Bringing new drugs onto the market can take years, so any delay will result in loss of income. Tremendous losses are sustained, if at the end of this long process, the competition then takes off with the innovation. The registration procedure, however, can be speeded up by the efficient transfer of technology between R&D and production. This transfer lays the foundations for the further production process, the control strategy, the process validation and the continuous improvement initiatives.
Lean Tech Transfer Framework
However, very few companies actually have policies in place, apply KPI’s or even have a standardised approach. Quality by Design has developed a Lean Tech Transfer Framework consisting of a scenario approach combined with templates. The framework serves as a lingua franca and ensures thorough understanding between both the sending and the receiving units. Adopting a risk-based approach will also increase the chances of success and improve efficiency.
What if there is a failure in the technology transfer process?
If anything goes wrong in technological transfer, the consequences can often be far-reaching. The processes will then be less robust and unreliable, the company will not meet its planned production figures, quality may cause concern, and the validation process may incur delays. In the worst case scenario, the drug registration may be in jeopardy. If this registration fails, the losses can be considerable. Delays through ineffective technology transfer may cost the company millions of euros in lost income every day.
Quality by Design bridges the knowledge gap
A technology transfer process involves a lengthy list of action points and checks. By focusing on the right 20%, you already have 80% of your project on track. That is the pragmatic principle applied by Quality by Design.
The Quality by Design validation experts and QA specialists bridge the knowledge gap between the sending and the receiving units. They are familiar with the processes on both sides, with the complex regulations and with the quality challenges facing the pharmaceutical industry. Quality by Design will guide you with the implementation of an approach for technology transfer based on scenarios and templates.