cGMP Property with Validation Loss Endorsement
What this clause says
Vendor shall maintain Property insurance on a manufacturer's property form covering buildings, equipment, in-process inventory, finished product, and cGMP-validation losses (including environmental excursion, cleanroom contamination, and HVAC failure), with limits sufficient to replace the largest single batch held on premises.
What this means in plain English
A property policy written specifically for drug manufacturers and 503B outsourcing facilities. Includes coverage for losses caused by cGMP excursions — environmental monitoring failures, sterility breaches, cleanroom contamination, HVAC and utility events — that generic commercial property forms exclude or sub-limit.
What it means for a CDMO program
cGMP-classed property forms are written by a small set of specialty markets. The validation-loss endorsement specifically covers batch losses caused by environmental or process excursions. For 503B operators and pharma manufacturers, generic pharmacy or general commercial property forms are materially inadequate.
Carrier notes
Premium varies widely based on facility size and batch values. A 503B with $20M in annual finished product flowing through cleanrooms typically pays $35K-$120K for the manufacturer-classed property program.
How this evaluates
The Decoder applies these rules in order; the first match wins.
- property › cgmp form is set → Compliant: cGMP property form in place.
- property › cgmp form is not set → Gap: No cGMP property form indicated.
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