What are current good manufacturing practices and how might we use them to create a snack mix that meets the regulations?
Students become Quality Assurance, Quality Control, and Manufacturing roles on a team to create a snack mix that meets CGMPs.
• B.H.1: Cellular Genetics
• B.H.5: Modern genetics
• 5.1.1. Use standard operating procedures for the safe use of instruments, equipment, and gas
cylinders.
• 5.1.4. Recognize clean room integrity using Standard Operating Procedures (SOPs).
• 5.1.8. Verify expiration dates and lot numbers.
• 5.1.10. Maintain an inventory system for manufactured products per standard operating
procedure (SOP).
• 5.1.11. Maintain separate in-processing, quarantine, and release areas.
• 5.5.12. Comply with industry-based and required regulatory quality-assurance practices (e.g.,
quality control [QC], Good Laboratory Practice [GLP], Good Manufacturing Practice [GMP]) for
documentation.
Biotechnology
• 3.1.14. Describe how biotechnology products are produced and used in the United States.
• 3.1.15. Describe how biotechnology products are regulated in the United States.
• 3.1.16. Describe biotechnology product safety assessment.
• 3.2.10. Describe industry-based and required regulatory quality assurance practices for
documentation.
Applied science roles involved in producing biological or chemical products.
Ensuring compliance, accuracy, safety, and communication of complex science.