Description
This three-day course is designed to provide a basic
understanding of the significant process development effort
involved in taking an R&D laboratory formulation to
commercial production. This course will focus on two main
areas:<br><br>
1. How to develop a pilot process suitable for scale-up to
commercial production.<br><br>
2. Factors to consider during scale-up and technology
transfer to take a product from formulation development to
the production floor.<br><br>
The course will review topics such as process flow and
equipment selection. Regulatory considerations, such as
documentation and a need for pilot scale products to be
representative of commercial production, will be discussed.<br><br>
Various technologies available for manufacturing dosage
forms will be reviewed in the context of scale-up parameters.
These will include processing methods for mixing, granulation,
compression and coating of solid dosage forms, as well as
processing methods for solutions, emulsions, suspensions
and sterile parenteral products.
