Technology transfer is a multidisciplinary approach which involves skilled staff

and individuals from different departments. A successful and productive technology

transfer requires the support and effort of different departments.

52 Industrial Pharmacy II

Basically there are four steps involved in transfer of technology:

1. Research phase 2. Development phase

3. Production phase 4. Documentation

1. Research phase: It involves the development of technology by the R&D department.

R&D department performs functions such as (a) procedure designing, (b) selection

of excipients.

R&D performs these functions by conducting different capability studies and

stability studies of the innovator product (the first approved product created

containing specific active ingredients for a particular use) and of the product which

is to be manufactured.

2. Development phase

a. Research for factory production: It is required to establish an appropriate quality

control method as well as a manufacturing method to manufacture the quality

product. It is done after detecting variability factors in the scale-up (which is set

up to establish factory design from results of small-scale production).

b. Consistency between quality and specification: After establishing an appropriate

quality control method and manufacturing method as mentioned above, it is

essential to confirm that the specification sufficiently specifies the product quality.

Associations between upper and lower limits of manufacturing as well as of upper

and lower of control limits of the product specification should be fully understood.

The consistency between the product quality and specifications should be

maintained to ensure in the product’s specification such that (a) the quality

predetermined in the quality design is assured as the manufacture quality,

(b) the product satisfies the quality of design.

c. Assurance of consistency through development and manufacturing: It is the

responsibility of “in charge” of the development of developers party to fully

understand the kind of technical information required by the receiver party in

charge of manufacturing and should establish a correct evaluation method to

establish the quality of design of drug to be manufactured.