BTEC 12A GLP and GMP Principles (1)
Lec-18, field trips
Credit, Degree Applicable
General overview of Food and Drug Administration regulations as they pertain to the biotechnology field. The course will emphasize cGLP, cGMP and SOP practices that pertain to biopharmaceutical laboratory and manufacturing facilities.
After successful completion of this course, students will be able to:
- Outcome 1: Explain the mission of the FDA.
- Outcome 2: Differentiate between criminal law, food law, and drug law.
- Outcome 3: Describe how the GLPs ensure the quality of study data.
- Outcome 4: Describe how the GMPs ensure product quality.
- Outcome 5: Define the term validation and explain why it is necessary.
- Outcome 6: List 7 product quality attributes and 4 components of a quality control program.
- Outcome 7: Name 2 purposes of GMP documentation.
- Outcome 8: Explain why SOPs are written and followed.
- Outcome 9: Write a sample SOP.
- Outcome 10: Summarize subparts and sections of GMP regulations.
- Outcome 11: Describe why gowning is important and which factors govern gowning requirements.
- Outcome 12: Describe the importance of proper cleaning procedures on the biopharmaceutical manufacturing line.
- Outcome 13: List 5 processing equipment signs/labels typically used in manufacturing
- Outcome 14: Describe how to prepare for an FDA audit.
- Outcome 15: Interpret sample FDA citations.