6. Packaging development It includes all the rationale for the choice of each packaging

report components

Packaging development procedures, testing limits for

packaging materials and all information about packaging

material formulation development, overages and biological

as well as physicochemical properties.

54 Industrial Pharmacy II

3. Production phase: It involves optimization and production by the following steps:

a. Validation and production: This is to verify if the production department is able to

consistently manufacture the product in accordance with the manufacturing

formula and with more degree of stability. Validation includes performance

qualification, process validation and cleaning validation.

b. Scale-up production: Scale-up is a step between lab-scale production and

commercial-scale production. It is done to target the problems which industry or

manufacturer can face while shifting the production from lab-scale to commercialscale. So, in scale-up production, a unit (which is larger than lab-scale but smaller

than commercial-scale) is set up. Each and every step related to the product is

performed at this stage. Before setting scale-up different parameters like flexibility,

cost, innovation, dependability, product quality are also considered which should

be optimum for successful technology transfer.

c. Selection of method: The best method for batch fabrication is selected on the basis

of data provided by R&D and feedback from scale-up production.

4. Documentation: Each and every step of the product cycle should be adequately

documented. Quality assurance department will check and approve the

documentation for each step.

4.4.1 Reasons for Technology Transfer

There are several reasons for technology transfer. Some reasons that facilitate developer

as well as receiver unit for technology transfer process are as follows:

i. Lack of resources for manufacturing capacity: The developer of technology may have

the capacity for small-scale production/operation or for laboratory-scale

production and want to associate with other organisation for large-scale

production.