These guidelines are flexible and provide a framework for the transfer of technology.
The main objective of these guidelines is to focus on quality aspects of products in line
with the WHO mandate. At any of the stages in the life cycle of drug products
(development, manufacturing, scale-up, production, market launch, and phase 4 clinical
trial), the transfer of the process to an alternative site can occur.
There has been a little knowledge on this subject of technology transfer which is
evident from the literature survey. Various national and international regulatory
agencies provide very little detail/information on technology transfer. International
Society for Pharmaceutical Engineering (ISPE) provides information and guidance
on intracompany transfers. But nowadays business strategies of pharmaceutical
companies are changing. Now it involves intra-company as well as the inter-company
transfer of technology. This is due to the need of: (a) Additional capacity, (b)
consolidations, (c) merges, (d) relocation of operations. So, WHO expert committee on
specifications for pharmaceutical preparations recommends in its 42nd report that
WHO addresses the issue of technology transfer and then guidelines came into
5.2 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 sites”.
Characteristics of TOT as per WHO
i. It is a systematic procedure.
ii. It involves passing of documented knowledge and expertise gained during the
development of the product to a responsible and authorized party.
No comments:
Post a Comment