6. Packaging development It includes all the rationale for the choice of each packaging
Packaging development procedures, testing limits for
packaging materials and all information about packaging
material formulation development, overages and biological
as well as physicochemical properties.
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
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
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
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