PDA Technical Report No.65 Revised 2022 (TR 65) Technology Transfer (Single user digital version)

This technical report aims to provide a standardized approach to the technology transfer process. It supplies a matrixed "Reference Guide to Technology Transfer Activities and Deliverables," which can be used to coordinate cross-functional technology transfer activities that help achieve operational readiness and culminate in regulatory approval. It is intended to provide a level of detail and approaches that can be applied across technology transfer types.

Designed to assist companies in the technology transfer process, this technical report covers the full range of requirements needed, such as new product introductions and the transfer of products that are being manufactured for phase III clinical trials or commercial release, which are the most comprehensive in nature. While the technical report was not specifically written for products at an earlier stage of development, many of the requirements can still be applied.

Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file 648 KB)

*To purchase licensing, please contact PDA at [email protected].