21 CFR 211.142 - Warehousing Procedures

What it says

Written procedures must describe storage of drug products under appropriate conditions of temperature, humidity and light, with quarantine procedures for materials awaiting release or rejection, and storage conditions adequate to prevent deterioration or contamination.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Storage condition control must be actively monitored and maintained, not simply specified on a label or procedure, since actual environmental conditions in a warehouse can drift from what is documented.
• Quarantine control in warehousing mirrors the same principle applied to incoming components under 211.80, requiring genuine physical or systematic separation between approved, quarantined and rejected material.
• Storage condition requirements are product-specific, meaning a single warehouse may need multiple distinct, monitored storage zones to correctly accommodate different products' requirements.

What FDA inspectors look for

• Whether temperature and humidity monitoring data for storage areas is continuously recorded and reviewed, with excursions investigated for potential product impact.
• Whether quarantined, approved and rejected material are genuinely segregated within the warehouse, not just administratively distinguished.
• Whether products with more stringent storage requirements, such as refrigerated or light-sensitive products, have dedicated, appropriately monitored storage zones.

Related regulations