Sever Pharma Solutions has vast experience from different types of technology transfers:
- from the customer’s R&D to Sever Pharma Solutions’s R&D
- from the customer’s R&D to Sever Pharma Solutions’s production
- from the customer’s production to Sever Pharma Solutions’s production
- from Sever Pharma Solutions’s production to someone else’s production
In each of these scenarios, our transfer procedures are fully in line with the ISPE Good Practice Guide: Technology Transfer.
Sever Pharma Solutions’s track record in technology transfer includes numerous cases where the sending party is either unable or unwilling to properly support the transfer process. In such instances, our project team applies statistical process control on historical raw data to gain the appropriate level of process understanding.
Sever Pharma Solutions has developed a structured approach to manufacturing transfer. It incorporates many fundamentals of good project management and Quality by Design philosophies (to enhance process understanding). The steps typically include:
- A historical review of the sending unit’s process, to assess its repeatability and robustness.
- A regulatory review to assess compliance between the regulatory file and the actual process.
- Training in analytical methods and process (using the historical review as a base).
- Analytical method transfer (see below).
- Process validation (based on conclusions from the historical review)
Typical transfer acceptance criteria includes:
- Conformance to release specifications
- Acceptable level of statistical control of the receiving unit’s process
- Similarity between the receiving and sending units’ processes
Transfer of analytical methods
In our experience, more variation is associated with the transfer of testing methods than the actual process transfer. As the receiving unit, Sever Pharma Solutions needs to adopt, substitute or supplement the sending unit’s methods. This requires comprehensive training in, and validation of these methods, based on the ISPE Good Practice Guide: Technology Transfer.