Manufacturing
Hold-Time Study
in-process hold time · bulk hold study
TL;DR
A validation study that establishes the maximum time intermediates, bulk product, or cleaned equipment can be held without affecting quality.
Hold-time studies determine how long an in-process material, bulk drug product, or cleaned-but-not-yet-used piece of equipment can be held before microbial, chemical, or physical attributes degrade. Approved hold times become operational limits enforced in the MMR/BMR.
V5 enforces hold times at the work-order step: the kiosk blocks restart once the validated window expires and routes the deviation automatically.
Regulatory anchors
- EU GMP Annex 15
- ICH Q7
Industries that live with this
Related terms
Want to see Hold-Time Study in V5?
Free trial, no credit card, onboard in days, not months.