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Research ArticleConference Proceeding

Raw Materials in the Manufacture of Biotechnology Products: Regulatory Considerations

Ruth Cordoba-Rodriguez
PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 445-450;
Ruth Cordoba-Rodriguez
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References

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    U.S. Code of Federal Regulations, Title 21, Part 211.80. Subpart E, Control of components and drug product containers and closures—General requirements. Office of the Federal Register, National Archives and Records Administration, U.S. Government Printing Office, Washington, DC. January 1, 2010.
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    U.S. Code of Federal Regulations, Title 21, Part 211.110. Sampling and testing of in-process materials and drug products. Office of the Federal Register, National Archives and Records Administration, U.S. Government Printing Office, Washington, DC. April17, 2008.
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    ICH Q7. Good manufacturing practice guide for active pharmaceutical ingredients. International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. September 25, 2001.
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    ICH Q5A (R1). Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. September 23, 1999.
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    ICH Q5D. Guidance on derivation and characterization of cell substrates used for production of biotechnological/biological products. International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. September 21, 1998.
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    Detection of adventitious viruses in biologicals—a rare occurrence. Dev. Biol. (Basel) 2006, 123, 153–164.
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    Orthogonal analytical approaches to detect potential contaminants in heparin. Proc. Natl. Acad. Sci. USA 2009, 106 (40), 16956–16961.
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PDA Journal of Pharmaceutical Science and Technology: 64 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 64, Issue 5
September/October 2010
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Raw Materials in the Manufacture of Biotechnology Products: Regulatory Considerations
Ruth Cordoba-Rodriguez
PDA Journal of Pharmaceutical Science and Technology Sep 2010, 64 (5) 445-450;

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Raw Materials in the Manufacture of Biotechnology Products: Regulatory Considerations
Ruth Cordoba-Rodriguez
PDA Journal of Pharmaceutical Science and Technology Sep 2010, 64 (5) 445-450;
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  • Article
    • Abstract
    • Introduction
    • Raw Materials Can Affect Product Quality, Safety, and Efficacy
    • Raw Materials in the Use of Cell Substrates
    • Raw Materials Need To Be Appropriately Controlled
    • Risk-Based Raw Materials Management
    • Risk Identification, Risk Analysis, and Risk Evaluation
    • Conclusions
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