Pharmaceutical Technology Transfer. 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. 101 product transfer may therefore occur during development during clinical trials or for full scale.
The challenge is how to establish process parameters with the new equipmentbatch size from the transferring manufacturing site to another site usually to the cmo chosen by the product owner while maintaining the quality. Ad tap into expertise resources to proactively address challenges avoid costly delays. With over 100 previously developed formulations that have already been registered in eu usa japan or australia dec has proven technology available for technical transfer tt and out licensing.
This knowledge forms the basis for the manufacturing process control strategy process validation approach and.
An fpp may contain one or more apis. Read all glossary in transfer of technology tot industrial pharmacy. Dec pharma provides a range of advanced technologies for the development of oral finished dosage forms fdf. Let us help you executive with speed agility to get to market fast.