Index/








Index/Lyophilization/







Scale Up to Manufacturing Site

A successful technology transfer ensures the quality of product during the entire life cycle of manufacture and validation, in accordance with current good manufacturing practices (cGMPs), providing predictable and consistent operation of the processes. TT based on the principles of Food and Drug Administration (FDA) International Conference on Harmonization (ICH) Q8, Q9, Q10, Q11 guidelines, involves knowledge transfer, science and risk-based approaches, and efficient processes transfer, which ensure a comprehensive and systematic transfer of information and documentation between transferring site and receiving site.

KAMAT has extensive experience in successful scale-up and transfer of many injectable products. Please refer to a research article, “Lyophilization Process Technology Transfer Towards Product Launch” by Dr. Kamat and Dr. Varshney on this subject.

© Kamat Pharmatech 2020