Certified Pharmaceutical GMP Professional Practice

What does the 'technology transfer' stage refer to in the product lifecycle?

1. The process of discontinuing a product

2. Transferring knowledge from development to manufacturing

3. The ongoing evaluation of a product

4. The approval of new products by regulatory bodies

The correct answer is: Transferring knowledge from development to manufacturing

The 'technology transfer' stage in the product lifecycle is primarily concerned with the process of transferring knowledge, technology, and processes developed during the product's development phase into the manufacturing environment. This stage is crucial for ensuring that the product can be produced consistently and reliably in commercial settings. It involves various activities, including the documentation of all relevant specifications, protocols, and methodologies, as well as training manufacturing staff and adapting the production processes to meet regulatory requirements and quality standards. This transfer is essential for bridging the gap between the research and development phase, where concepts and formulations are created and tested, and the manufacturing phase, where those products are produced at scale. Successful technology transfer helps minimize discrepancies in product quality and ensures that the final product meets all necessary compliance and regulatory requirements, thereby supporting the overall integrity of the product lifecycle.