Start with a Gap and Risk analysis
Technology transfer is a complex and time-consuming undertaking, especially since multiple partners and sites are involved. Any knowledge of the existing process at the sending site and the envisioned process at the receiving side must be identified, including:
- Filing strategy
- Critical quality attributes (CQAs) to achieve the target product profile (TPP)
- Logistical procedures
- Analytical methods
- Equipment, materials, and instructions
- Organizational issues
The major elements necessary for robust, reproducible manufacturing include a combination of gap and risk analysis to assist in identifying and evaluating any knowledge gained from the development and manufacturing process of the drug. It is also necessary for assessing the risk of any identified differences between transfer sites.
Potential risks to the product quality attribute, process and regulatory consequences must then be identified and, possibly, new process parameters established. At the receiving site, process design is necessary to accommodate the known and newly-identified critical process parameters (CPPs) to meet critical quality attributes. Process qualification to verify constant quality, the establishment of a control strategy at the receiving site, as well as the identification and controlling of sources of variability in material and processes are also necessary.