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

62 Industrial Pharmacy II

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

back to SU.

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

technology transfer.

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.