Technology Transfer Plays an Increasingly Important Role in Pharmaceutical Quality Systems

Technology transfer is a critical step in the first stage of the development life cycle of pharmaceutical drugs. For a successful technology transfer to take place, all prior knowledge, data, and expertise must be gathered as a basis for developing a manufacturing control strategy. In the following steps, knowledge of production, analytics, and processes gathered from development can be transferred to the manufacturing sites. Some of the key activities that should be undertaken to ensure a successful technology transfer are:

1. Documentation of product & process knowledge
2. Building an integrated cross-functional team of experts
3. Technology evaluation and development
4. Execution & continuous monitoring

A final manufactured product that is robust in nature is often a result of a well thought-out plan that is executed with diligence. A plan that includes the inputs from various stakeholders such as research, development, manufacturing technical operations, quality control, and manufacturing is highly recommended.

In addition to the above, a quality by design approach helps to ensure that a desired technology is successfully transferable. Knowing where and when quality could be affected and understanding measurements of capability such as repeatability and precision, is a crucial characteristic of quality by design. Using the principals of the approach will generate the desired robust and safe products.

At Modis Life Sciences, our supply chain experts and consultants can help you evaluate how Technology Transfer can boost your business, while our experienced project managers can help you prepare and implement the transfer successfully.​

– Diane Steel, Project Manager

Source: