vi. There should be an effective process and product knowledge transfer.
Technology transfer will be considered successful if:
i. RU is capable of producing/reproducing the product, method or process that
was transferred (it must be proved with documented evidence) on a predefined
set of specifications as agreed with the SU.
Fig. 5.1: Units involved in the transfer of technology
ii. The continuous knowledge management system is maintained in case RU faces
any problem with the process during transfer so that RU can easily communicate
iii. There will be no lack of transparency.
iv. Any issues that have legal and economical implications such as IPR’s, royalty,
pricing, confidentiality, interest are expected to have any impact on open
communication, then it must be mentioned before or during the execution of
5.3 SCOPE OF WHO GUIDELINES FOR TOT
i. The scope of these guidelines is very wide. It covers all the technology transfer
process aspects where a technical agreement exists. The technical agreement can
be between RU manufacturer and SU manufacturer or between SU manufacturers
to RU quality control laboratory. However, many points are not workable and
alternative approaches may be required in case of no such technical agreements.
ii. This document gives guidance in principle. It provides general recommendation
related to the activities required for successful intertransfer or intratransfer of
technology. It addresses the basic consideration for successful transfer to fulfil
the expectation of regulatory authority.
iii. These guidelines are apply to manufacturing API, manufacturing and packaging
of bulk materials, of finished products packaging and analytical testing.
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