Abstract
Good Manufacturing Practices (GMPs) and Good Tissue Practices (GTPs) are based on the recognition that quality cannot be determined by examining or testing a finished product. Rather, the quality, safety, and efficacy of a product must be established throughout the manufacturing process. Another major tenet of GMP/GTP is “if an activity was not documented, it was not done.” Both quality oversight and documentation are largely facilitated by use of Standard Operating Procedures (SOPs). This chapter reviews the structure and development of SOPs.
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Useful Literature
FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration. 4th edition, October 2008.
NETCORD-FACT International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection and Release. 3rd edition. FACT-NetCord, Omaha, NE. 2006.
AABB, Standards for Cellular Therapy Product Services. 3rd edition. AABB, Bethesda, MD. 2008.
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© 2009 Springer Science+Business Media, LLC
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Lindgren, C. (2009). Standard Operating Procedures. In: Gee, A. (eds) Cell Therapy. Springer, Boston, MA. https://doi.org/10.1007/b102110_10
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DOI: https://doi.org/10.1007/b102110_10
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