Derivation of the clinical grade fibroblast line NclFed1A. (a) A detailed description of the Quality Management System (QMS) required for processing cells to good manufacturing practice (GMP; passaging of NclFed1A). (b) Schematic showing the general processes involved in deriving a fibroblast cell line under the control of GMP. "Upstream" includes all processes that are in place before the derivation and expansion of the fibroblast line. "Downstream" refers to biosafety and functionality testing of the line.