BTEC 12B GMP Compliance (1)
Lec-18, field trips
Credit, Degree Applicable
Detailed discussion of the systems (procedures and documents) required to achieve compliance with the FDA Good Manufacturing Practice regulations as they relate to biopharmaceutical manufacturing.
After successful completion of this course, students will be able to:
- Outcome 1: Explain the FDA regulations for product labeling.
- Outcome 2: List the major stages of validation and identify common validation documents.
- Outcome 3: Explain why batch records are kept and monitored closely.
- Outcome 4: Write a sample batch record.
- Outcome 5: Evaluate a cleaning scenario and determine if the equipment is clean. Identify three sampling methods for determining equipment contamination.
- Outcome 6: Explain why raw materials are quarantined.
- Outcome 7: Assess laboratory control case studies and describe what errors occurred.
- Outcome 8: Define the importance of process control.
- Outcome 9: Identify what must be documented when managing changes and describe what two impacts must be considered.
- Outcome 10: Name two purposes of a FDA form 483 following a FDA inspection.