According to WHO, Technology transfer (TT) is defined as “The transfer of the manufacturing process for a new pharmaceutical Drug Substance (DS) and Drug Product (DP), respectively, from the transferring site (in this case R&D) to the receiving site or designated commercial manufacturing site.
Major Steps of Technology Transfer Activities
1. Identification of technology
2. Documentation and knowledge transfer
3. Selection of transfer team
4. Gap analysis
5. Risk assessment
6. Development of transfer plan
7. Training and qualification
8. Process validation
9. Regulatory submission
10. Continuous improvement
11. Post-transfer support
A typical technology transfer process can be divided into production part, quality control part and documentation part.
Throughout lifecycle stages, transfers should be appropriate and proportionate to the phase of the product life cycle in order to ensure that product knowledge is maintained and that processes are appropriately controlled.
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