Cell Therapy & Gene Therapy Equipment worked example

GMP Deviation Cost at 86% deviation cost assigned to this scope: a worked example

What does the result look like when deviation cost assigned to this scope reaches 86%? The full calculation is worked below with real intermediate numbers. a GMP quality team is estimating the cost exposure from deviations in a batch, campaign, suite, or equipment program

The inputs for this scenario

  • Expected GMP deviation events: 12 deviations (unchanged)
  • Average investigation cost per deviation: 9,500 $ / deviation (unchanged)
  • Deviation cost assigned to this scope: 86 % (raised for this scenario; the documented default is 75)
  • Fixed CAPA or remediation cost: 35,000 $ (unchanged)

Working through the calculation

  • Applying the documented formula (Allocated investigation cost = expected GMP deviations × average investigation cost × assigned share) to the inputs above produces each figure below.
  • At this operating point the engine returns 133,040 $ deviation cost for total gmp deviation cost, the number this scenario is built around.
  • At this operating point the engine returns 11,087 $ / deviation for deviation cost per event.
  • At this operating point the engine returns 98,040 $ for allocated investigation cost.
  • At this operating point the engine returns 35,000 $ for fixed capa or remediation cost.

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 10.41% above the baseline at 133,040 $ deviation cost.
  • A figure at this level is achievable when deviation cost assigned to this scope is genuinely sustained, not just peaked for a shift. It uses an average investigation cost; in reality CGT deviations range from a quick like-for-like component swap to a multi-month critical investigation with batch rejection, so a single average can understate the cost of rare, severe events.

Results at a glance

  • Total GMP deviation cost: 133,040 $ deviation cost (headline result)
  • Deviation cost per event: 11,087 $ / deviation
  • Allocated investigation cost: 98,040 $
  • Fixed CAPA or remediation cost: 35,000 $

Run it with your numbers

  • Every input above is editable in the live GMP Deviation Cost calculator, which recalculates instantly and can be shared with the inputs intact.

Last reviewed 2026-05-12.