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Technology Transfer (Second Edition)

2014-07-08 by ISPE Korea

 

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:

• Science and risk-based (“Quality by Design”) principles described in ICH Q8 Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System and ICH Q11 Development and Manufacture of Drug Substance, including reference to Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), Design Space (where used) and, in particular, Control Strategy.
• Alignment with the process validation concepts and life cycle approach as described in, for example, FDA Process Validation Guidance, Jan 2011.
• The critically important area of the transfer of knowledge as a key part of technology transfer and as a component of the overall life cycle knowledge management process

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:

• Analytical Procedures Technology Transfer
• Drug Substance (Active Pharmaceutical Ingredients (APIs)) Technology Transfer
• Drug Product (Dosage Forms manufacturing processes) Technology Transfer

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.:

• laboratory to laboratory scale
• laboratory to development/pilot scale
• development to clinical manufacturing
• development to launch/commercial manufacturing
• drug substance to secondary manufacture
• lead manufacturer to third party manufacturer
  
  Appending : Table of Contents
  
  
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  www.ispe.org > Knowledge & Learning > Guidance Documents
  

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