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. Author manuscript; available in PMC: 2016 Apr 1.
Published in final edited form as: Cytotherapy. 2014 Dec 4;17(4):339–343. doi: 10.1016/j.jcyt.2014.10.008

  • Processing and Manufacturing SOPs

  • Donor Testing

  • Raw Materials
    • Cell or Tissue Source (components)
    • Gene Therapy (vector or genetically modified cell)
    • Reagents and Associated Certificates of Analysis (CoA)
    • Cell or Tissue Source (components)

  • Product Safety & Quality Testing

  • Potency Assays

  • Product Stability

  • Other Controls (product container closure, labels, tracking)

  • Equipment Specifications

  • Environmental assessment or claim for exclusion in accordance with 21 CFR 312.23(a)(7)(iv)(e)