Dear Vasu vasanth,

Transfer of technical information is necessary to realize manufacturing formula established in the above in the actual production facility. In the past, the technology transfer was mainly seen as standard transfer or as technology instruction from technology department to production department within the same company. ,the technology transfer between companies will increase. In principle, how accurately transfer technical information (know-how) from transferring party to transferred party is important, and it is essential to establish responsibility system and prepare documents.. When transfer technology of new products from research and development department to production department, technical information to be transferred should be complied as research and development report (development report and recommend to use the development report as a part of technology transfer documentations). Production is implemented after various validation studies verify that it is able to stably produce based on transferred manufacturing formula. While the manufacturing facility accepting technology is responsible for validation, the research and development department transferring technology should take responsibility for validations such as

1.       Performance qualification (PQ), cleaning validation,

2.         Process validation (PV) unique to subject drugs.

3.       For validations such as installation qualification (IQ) and

4.        Operational qualification (OQ), which are not unique to the subject drugs,

 it is possible to effectively use data of already implemented validations.

Regards,

Prem Baboo

Vasu,

Agreed with Prem. Technology Transfer ensures trial, scale, exhibit and validation of technology recommended by RnD and feasibility @ Manufacturing facility.

Prem,

Very useful information.

Thanks, Bhargava

Thanks for Bhargava and Prem Baboo.