This module provides students with an appreciation
of good manufacturing practices (GMP) as a set of
guidelines for the regulation of food, pharmaceuticals,
biopharmaceuticals and medical devices, as well as
their role in related industries. It encompasses the
approaches taken in the development of manufacturing
systems, quality assurance, quality control, validation
and regulatory audits, and covers validation plans such
as cleaning validation and analytical method validation.
Students will learn about facility design and layout
including cleanroom design and requirements and water
supply systems for production use. The module encourages
the development of skillsets such as process control
techniques and measurement system analyses that are
widely used in the manufacturing industry. It also covers
the roles and responsibilities of the Food and Drug
Administration (FDA) and other safety authorities.
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