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ICH stability zones (IVb hot-humid)

In short

ICH stability zones translate global climate into testing conditions: Zone I 21°C/45% RH, Zone II 25°C/60% RH (US/EU baseline), Zone III 30°C/35% RH (hot-dry), Zone IVa 30°C/65% RH and Zone IVb 30°C/75% RH (hot-very-humid: ASEAN, Brazil, Caribbean). A supplement programme inte...

ICH stability zones translate global climate into testing conditions: Zone I 21°C/45% RH, Zone II 25°C/60% RH (US/EU baseline), Zone III 30°C/35% RH (hot-dry), Zone IVa 30°C/65% RH and Zone IVb 30°C/75% RH (hot-very-humid: ASEAN, Brazil, Caribbean). A supplement programme intended for ASEAN or LATAM distribution runs Zone IVb long-term in addition to Zone II — and bracketing/matrixing per ICH Q1D cuts the cost.

Regulatory anchors
  • ICH Q1A(R2)
  • ICH Q1F
How V5 handles it
QMS — quality records next to the work they concern.
Deviations, corrective actions and quality review sit in the same system as production, so each quality record references the work order, step and lot it concerns.
Document control — one version in force, every change signed and explained.
Draft the next revision while the current one stays in use, approve it under your sign-off route, and track training on it — with the history kept.
Related terms
Bracketing & matrixing (ICH Q1D)Supplement Stability & Shelf LifeICH Q1AICH Q1A Stability Storage Conditions
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