Introduction - Bioprocess Engineering: Kinetics, Biosystems, Sustainability and Reactor Design - page 20

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Moberg, C.L., 1991. Penicillin's forgotten man: Norman Heatley. Science 253, 734 e 735.
Sheehan, J.C., 1982. The Enchanted Ring. The Untold Story of Penicillin. MIT Press, Cambridge, MA.

E. Regulatory Issues
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Product Liability Committee, O'Melveny & Myers LLP.
Durfor, C.N., Andscribner, C.L., 1992. An FDA perspective of manufacturing changes for products in human use.
Ann. NY Acad. Sci. 665, 356 e 363.
Naglak, T.J., Keith, M.G., Omstead, D.R., 1994. Validation of fermentation processes. Biophann (July/Aug.) 28 e 36.
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http://www.FDA.gov
http://www.FDAreview.org/approval_process

PROBLEMS

1.1. Why are renewable materials preferred?

1.2. What is green chemistry?

1.3. What is sustainability?

1.4. What is a biorefinery?

1.5. Why is ethanol an important platform chemical?

1.6. An uninformed researcher is questioning the sustainability of biomass cultivation and

utilization, arguing that fertilizer and fuels for heavy machinery must be produced
with fossil energy and thus not renewable. Research into the basis of the arguments and
dismiss the notion of unsustainable biomass use.

1.7. What is GMP and how does it relate to the regulatory process for pharmaceuticals?

1.8. When the FDA approves a process, it requires validation of the process. Explain what

validation means in the FDA context.

1.9. Why does the FDA approve the process and product together?

1.10. What is biotransformation? What is chemical transformation?