Description
All biopharmaceutical products are manufactured in a
regulated environment to ensure the quality and safety of
these substances. Biopharmaceutical facilities are licensed
to manufacture a specific product and are inspected by
regulatory agencies such as: FDA, European Agency for
the Evaluation of Medicinal Products (EMEA), and
Medicines Control Agency (MCA) in the UK. These
agencies provide a framework for process equipment
GMP requirements. Process equipment suppliers also
offer specific design features to optimize operation,
cleaning and maintenance of integral production modules.<br><br>
Design specifications for biological process equipment
including process requirements and functional
requirements to define material selection, instrumentation
and controls, and for interfacing with facility utility systems
will be discussed. Process and facility validation
requirements for the process modules will be related to
their ultimate use. Finally, the process unit modules must
be able to operate and perform as an integrated
production train. Practical solutions to real issues will be
emphasized.
