ISPE Releases Good Practice Guide: Technology Transfer 3rd Edition

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This Guide provides industry good practices for successful and efficient execution of technology transfer projects.

ISPE Good Practice Guide: Technology Transfer 3rd Edition
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

The International Society for Pharmaceutical Engineering (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.

The new ISPE Good Practice Guide: Technology Transfer 3rd Edition is available online at http://www.ISPE.org/Publications/Guidance-Documents.

About ISPE
The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,500 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland USA, and its operations center in Tampa, Florida USA. Visit http://www.ISPE.org for more information.

For more information, contact:
Maria Robertson
Senior Director, Marketing Communications
International Society for Pharmaceutical Engineering (ISPE)
Tel: +1-301-364-9207
Email: mrobertson(at)ispe.org
http://www.ISPE.org

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Maria Robertson
ISPE
301-364-9207
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