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Facility Equipment

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Cell Therapy
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Abstract

Control of laboratory equipment is critical in a cGMP facility. Equipment management ensures compliance with all regulations and standards and documents the lifecycle of the equipment, encompassing product selection, installation, validation, maintenance and disposal.

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References

  1. Mettler Toledo website: http://us.mt.com/us/en/home/supportive_content/know_how.QM_Equipment_Qualification_EN.twoColEd.html; November 1, 2006.

  2. Team Leader Assessment of Director & Quality Checklist for CAP Accreditation, College of American Pathologists. September 2007.

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  3. Title 21 Code of Federal Regulations Part 1271.200 (Good Tissue Practices) May 25, 2004.

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  4. Title 21 Code of Federal Regulations Part 211 Subpart D (Good Manufacturing Practices – Pharmaceuticals) May 25, 2004.

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  5. Title 21 Code of Federal Regulations Part 606 (Current Good Manufacturing Practice for Blood and Blood Components) August 16, 2007.

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  6. Laboratory General Checklist for CAP Accreditation, College of American Pathologists. September 2007.

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  7. FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration. 4th edition, October 2008.

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  8. AABB. Standards for Cellular Therapy Product Services, 3rd edition, AABB, Bethesda, MD, 2008.

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Correspondence to D.L. Griffin MS .

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© 2009 Springer Science+Business Media, LLC

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Griffin, D. (2009). Facility Equipment. In: Gee, A. (eds) Cell Therapy. Springer, Boston, MA. https://doi.org/10.1007/b102110_15

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