BTEC 12A GLP and GMP Principles (1)
Lec-18, Lab-6, field trips
Credit, Degree Applicable
This course provides a general overview of Food and Drug Administration regulations as they pertain to the biotechnology field. Knowledge of Current Good Laboratory Practices (cGLP) and Current Good Manufacturing Practices (cGMP) is needed to work in biotechnology manufacturing and preclinical research laboratories. The course will emphasize practices of cGLP, cGMP and SOP that pertain to biopharmaceutical industry.
After successful completion of this course, students will be able to:
- Outcome 1: Explain the historical events that led to the creation of good laboratory practices (GLP), good manufacturing practices (GMP) regulations, and the Food and Drug Administration (FDA).
- Outcome 2: Describe how the FDA insures the safety and efficacy of drugs and biologics.
- Outcome 3: Describe the role of quality assurance (QA) and quality control (QC) in the development of drugs and biologics.
- Outcome 4: Apply principles of GLP and GMP to work in a regulated biotechnology setting.