Cell Therapy & Gene Therapy Equipment worked example

GMP Deviation Cost at 54% deviation cost assigned to this scope: a worked example

This worked example runs the gmp deviation cost numbers for a tougher week than the baseline: 54% deviation cost assigned to this scope instead of the typical 75%. Estimate expected cost from deviations, investigations, CAPAs, and repeat work in cell and gene therapy manufacturing.

The inputs for this scenario

  • Expected GMP deviation events: 12 deviations (held at the documented default)
  • Average investigation cost per deviation: 9,500 $ / deviation (held at the documented default)
  • Deviation cost assigned to this scope: 54 % (the input this scenario stresses; the baseline uses 75)
  • Fixed CAPA or remediation cost: 35,000 $ (held at the documented default)

Working through the calculation

  • The calculation starts from the formula this tool documents: Allocated investigation cost = expected GMP deviations × average investigation cost × assigned share.
  • Total GMP deviation cost works out to 96,560 $ deviation cost at these inputs, and this is the headline figure for the scenario.
  • Deviation cost per event works out to 8,047 $ / deviation at these inputs.
  • Allocated investigation cost works out to 61,560 $ at these inputs.
  • Fixed CAPA or remediation cost works out to 35,000 $ at these inputs.

How this compares with the baseline

  • Against the tool's baseline example, where deviation cost assigned to this scope sits at 75% and the headline result is 120,500 $ deviation cost, this scenario comes in 19.87% below the baseline at 96,560 $ deviation cost.
  • Use it to budget the quality cost of a process or suite, to build the business case for automation or design changes, or to compare deviation exposure between platforms or sites. A result at this level usually justifies acting on the stressed input before touching anything else, because every other figure in the table is downstream of it.

Results at a glance

  • Total GMP deviation cost: 96,560 $ deviation cost (headline result)
  • Deviation cost per event: 8,047 $ / deviation
  • Allocated investigation cost: 61,560 $
  • Fixed CAPA or remediation cost: 35,000 $

Run it with your numbers

  • To rerun this with your own numbers, open the live GMP Deviation Cost calculator, set deviation cost assigned to this scope to your actual value, and adjust the remaining inputs to match your operation.

Last reviewed 2026-05-12.