Whether technology transfer involves site-to-site transitions, in-house scale up, contractual services, or any combination of these, the goal is to have the new process produce results that are as close as possible as the original. A comprehensive and thorough technology transfer approach leverages risk identification and evaluation. This article highlights different technology transfer models, the key elements of a successful tech transfer and aspects that are often overlooked, risk management tools, approaches to due diligence, the value of implementing PAT and process understanding, and ensuring compliance of 21 CFR part 11 and other regulations.

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