vii. Packaging development report
Reasons for Technology Transfer
There are several reasons for the technology transfer. Some reasons that facilitate
developer as well as a receiver unit for technology transfer process are as follows:
i. Lack of resources for manufacturing capacity
ii. Lack of resources related to marketing and distribution capabilities
iii. Lack of resources for commercial launch of product
iv. Lack of resources for conducting clinical trials
v. Lack of resources for exploitation of technology
i. Technology transfer from government sector to private sector
ii. Technology transfer between private sectors of the same country
iii. Between private sector firms of different countries
iv. From academia to private sector
v. Academia, government and industry collaborations
Methods of Technology Transfer
vii. Foreign company acquisition
ix. Original equipment manufacturer
WHO GUIDELINES FOR TECHNOLOGY TRANSFER
WHO guidelines for technology transfer are mentioned in Annexure 7 of WHO
Technical Report Series No 961, 2011 as “WHO guidelines on transfer of technology in
pharmaceutical manufacturing”.
Introduction: These guidelines are flexible and provide a framework for transfer of
technology. The main objective of these guidelines is to focus on quality aspects of
products in line with WHO mandate.
Transfer of technology (TOT) as per WHO: TOT is defined as “a logical procedure
that controls the transfer of any process together with its documentation and
professional expertise between development and manufacture or between manufacture
Organization and management: The transfer of technology includes SU and RU, in
some cases an additional unit (which is responsible for directing, managing and
approving the transfer). The main objective of organization and management in
technology transfer is to ensure that main steps of TOT should have been properly
executed and documented as well.
Quality risk management: In most of the countries compliance with GMP
throughout the product life cycle largely gives assurance regarding good quality of
product. However, any lose control can put patients at risk because of lower quality of
medicine. Regulatory authorities can improve the quality of the product within the
limit of resources available if:
a. Assessment of individual risk relates to specific products, starting material is
b. Recognition of hazards at specific stages of production and/or distribution is
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