ISPE Good Practice Guide: Technology Transfer, Third Edition

by ISPE

Transfer of manufacturing processes and analytical procedures between facilities or laboratories is a necessary part of pharmaceutical development and commercialization. Technology transfers take the outputs of process or method development activities and transfer the knowledge to a different location where a process or analytical procedure will be operated. This third edition Guide presents industry good practices for successful and efficient execution of technology transfer projects. It intends to achieve a balance between risk management and cost effectiveness while aligning with applicable regulatory expectations.

Paperback

Published January 1, 2018