PDA TR 65

This technical report covers the full range of requirements needed for TTs, 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. In transfers of products at an earlier stage of development, when process and product knowledge is less understood and therefore CMC requirements are less detailed, certain steps described in this technical report will not be necessary. This report does not detail those differences.

While this information was not developed specifically for medical devices, combination products, and advanced therapy medicinal products due to their unique requirements, many of the fundamentals expressed here can be applied to those products.

For this technical report, it is assumed that all involved parties have established systems for commercial production. Thus, standard requirements such as equipment and facility maintenance, annual product reports, lifecycle validation, complaint handling, and continued process verification (CPV) programs are not addressed. For purposes of this technical report, the TT ends with the handover to operations upon regulatory approval.