BIT 155 - Quality Control and Good Manufacturing Practices

3

Formerly BI 2121

The role of current good manufacturing practices (CGMPs) and a quality assurance department in the development and manufacture of quality biotechnology products. Emphasis is placed on understanding the basic principles upon which these regulations are based. Topics include the goals and obligations of the Food and Drug Administration, a review of CGMP subparts as key ingredients in the production of quality products, and the responsibilities of a quality assurance department in product quality.

Prerequisite(s): BIO 131 (SC 2101), CHE 121 (SC 3121), ENG 101 (EN 1103), TMA 090 (MA 3123).


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