ISPE Good Practice Guide: Technology Transfer

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

The Guide is intended to provide an approach on how to perform technology transfer. Not all the activities described in this Guide will apply to every system. Organizations may select activities appropriate to the type and scale of technology tranfsfer being performed.

Product Details

Edition:

2nd

Published:

05/01/2014

ISBN(s):

9781936379712

Number of Pages:

84

File Size:

1 file , 5.4 MB