ISPE Good Practice Guide: Technology Transfer 3rd Edition Released
ISPE announced the release of their latest Guide, ISPE Good Practice Guide: Technology Transfer 3rd Edition. This Guide provides industry good practices for successful and efficient execution of technology transfer projects.
“Transfer of manufacturing processes and analytical procedures between facilities or laboratories is an essential part of pharmaceutical development and commercialization,” said John Bournas, ISPE CEO and President. “This Guide was designed by an international team to help users achieve a balance between risk management and cost effectiveness while aligning with applicable regulatory expectations.”
From this Guide, users will learn:
- About industry developments and potential regulatory impacts
- Why knowledge management is a critical component of effective technology transfer
- How to align with the process validation concepts and lifecycle approach
Updates to this third edition of the Guide were to ensure alignment with relevant guidance publications and terminology used by industry and regulators, using practical case studies as examples.
