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Supply Management

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Cell Therapy

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Abstract

Both Good Manufacturing Practice (GMP) and Good Tissue Practice (GTP) regulations address the management of supplies used in the manufacture of drugs and cellular therapy products. In addition, a controlled and auditable procedure for the management of supplies and reagents is essential to provide traceability, and to ensure that products are manufactured using safe and appropriate components. This chapter describes procedures for developing and implementing a supply management system.

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Useful Literature

  1. cGMP in manufacturing, processing, packing, or holding of drugs and finished pharmaceuticals. Title 21 Code of Federal Regulations, Parts 210 and 211.

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  2. Human cells, tissues and cellular and tissue-based products. Title 21 Code of Federal Regulations, Part 1271.

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  3. Current good manufacturing practice and investigational new drugs intended for use in clinical trials. Final rule. Federal Register 73, 40453, 2008.

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  4. Guidance for Industry – CGMP for Phase 1 Investigational Drugs, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Office of Regulatory Affairs, July 2008.

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Acknowledgments

The authors are grateful to the staff of the Center for Cell and Gene Therapy (CAGT) for their help in the preparation of this article, and especially to Carlos Lee and Crystal Silva-Lentz for their suggestions and the photographs.

Author information

Authors and Affiliations

  1. Baylor College of Medicine, Center for Cell and Gene Therapy, 77030, Houston, TX, USA

    A. Gee MI Biol, PhD & C.M. Rooney PhD

Authors
  1. A. Gee MI Biol, PhD
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  2. C.M. Rooney PhD
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Editor information

Editors and Affiliations

  1. Baylor College of Medicine, Baylor Plaza 1, Houston, 77030, U.S.A.

    Adrian Gee

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© 2009 Springer Science+Business Media, LLC

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Gee, A., Rooney, C. (2009). Supply Management. In: Gee, A. (eds) Cell Therapy. Springer, Boston, MA. https://doi.org/10.1007/b102110_14

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