Technology transfer has become a key process in the pharmaceutical industry with increased scrutiny from regulatory agencies. The number of technology transfer activities is growing within and across company boundaries in the global environment.
Types of transfer
A company often has to transfer products, processes and technologies to other sites and manufacturers for commercial and logistical reasons. Transfer of technology is a systematic process that ensures the standards of quality, potency and safety of pharmaceuticals. The number of potential technology transfers is vast and challenging. Technology transfer is a process that spans the key phases of pharmaceutical development through to commercial manufacturing including:
- Product transfers including API and drug product manufacture
- Processing, packaging and cleaning operations
- Quality control – analytical method transfer
PDS can help you navigate the complex requirements of technology transfer and by providing:
- Awareness of regulatory guidances
- Advice on technology transfer strategy
- Regulatory and technical gap analyses of the sending and receiving site
- Technology transfer planning and documentation
- Direction to avoid making common mistakes in technology transfer.