Transfer of manufacturing processes, or technology transfer, is an essential piece 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 knowledge forms the basis for the manufacturing process, control strategy, process validation approach and ongoing continual improvement.

Technology transfer projects may take place at various times during the product life cycle. They require partnership and coordination between Sending Units and Receiving Units to ensure successful and efficient completion of a project, such that the Receiving Unit can successfully manufacture, test and release a safe, effective and quality product.

The second edition of the ISPE Good Practice Guide: Technology Transfer focuses on processes for transferring technology between two parties. The guide presents industry best practices for execution of efficient technology transfer projects and balancing risk management and cost effectiveness while aligning with applicable regulatory expectations.

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What approaches are you using to achieve compliance in your technology transfer operations?