Published: May 2014
Table of Contents ( 688 KB)
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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 second edition of the ISPE Good Practice Guide: Technology Transfer, has been revised to align with concepts and terminology used in industry, and regulatory developments, including:
The Guide also presents industry good practices for successful and efficient execution of technology transfer projects and to achieve a balance between risk management and cost effectiveness while aligning with applicable regulatory expectations. It covers the principles of technology transfer and also provides some tools for its practical application.
This Guide is intended to be used as a generic guide to technology transfer in combination with a compilation of information under three specific topics:
This guide is intended to provide information in relation to Technology Transfers that may take place between two parties (a Sending Unit and a Receiving Unit) in regard to any applicable transfers in the product life cycle, e.g.: