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Technical information transfer is required to realize the production formula described above in the actual production facility. In the past, technology transfer was mainly seen as standard transfer or as technology direction from technology department to manufacturing department within the same company. In the future, as contract manufacturing is expected to increase under the revised Pharmaceutical Affairs Act, technology transfer between companies will increase. In principle, it is important to correctly transfer technical information (how) from the transferring party to the transferred party, and it is essential to establish responsibility systems and prepare documents clarifying the 5 W’s and 1 H’s, and to exchange adequate technology between the two parties. Successful transfer.
When transferring the technology of a new product from the research and development department to the production department, the technical information should be transferred as a research and development report (it is recommended to use the development report as a part of the development report and technology transfer documentation).
