Sever Pharma Solutions has vast experience with different types of technology transfers:
Our transfer procedures align with each service’s ISPE Good Practice Guide: Technology Transfer.
Sever Pharma Solutions’ track record in technology transfer includes numerous cases where the sending party cannot or unwillingly support the transfer process properly. In such instances, our project team applies statistical process control on raw historical 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:
Typical transfer acceptance criteria include:
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 and validation of these methods, based on the ISPE Good Practice Guide: Technology Transfer.
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