Written and maintained by CASRAI Editorial Board
Last updated
Not medical advice. This page gives general information about storage facilities for medical products. It does not tell any person how to use or store a product for care, and it is not a compliance opinion.
Short answer
A medical warehouse is a building or area where medical products (medicines, medical devices including in vitro diagnostics, and vaccines) are received, stored, picked, packed and dispatched under controlled conditions. The WHO’s good storage and distribution guidance asks for secure premises, separated zones for goods that are not yet released, storage inside the temperature limits on each product’s label, and records that prove it. A medical supply warehouse is the same idea applied to supplies and devices.
Definition and scope
WHO Technical Report Series No. 1025, Annex 7 (2020) defines “medical products” as products including, but not limited to, finished pharmaceutical products, medical devices including in vitro diagnostic medical devices, and vaccines. It defines “storage” as the storing of medical products up to the point of use. Its premises section (clause 12.1) expects premises suited to receiving, storage, picking, packing and dispatch.
Two scope points prevent common errors:
- The WHO text is guidance, not law. It says that, depending on national and regional legislation, the guidelines may apply to human and veterinary pharmaceutical products and other medical products.
- The US drug rule covers drugs only. 21 CFR 211.142 requires written warehousing procedures for drug products, including quarantine before release by the quality control unit and storage under appropriate conditions of temperature, humidity and light. It does not set device rules. FDA’s Quality Management System Regulation became effective on February 2, 2026 and incorporates ISO 13485:2016 by reference for device manufacturers’ quality systems.
How goods move through a medical warehouse
The WHO guidance describes a flow that maps onto physical zones. The clause numbers below are from Annex 7.
Receiving
Receiving and dispatch bays are separate where possible and protect products from the weather (12.5). Each incoming delivery is checked against its documentation: purchase order, containers, label description, batch number, expiry date and quantity (12.10), and for contamination, tampering and damage (12.12). Temperature-controlled goods are handled as a priority and transport temperature data is reviewed on receipt (12.16).
Quarantine
Suspect containers are quarantined. Batches stay segregated during quarantine (12.15) and are not moved to saleable stock until an authorized release is obtained (12.17). Returned products are placed in quarantine on receipt (9.2). Rejected products are segregated and stored securely (12.18). Status areas must be clearly marked with restricted access, and a computerized replacement for physical separation must be validated (12.26).
Storage
Products are stored off the floor, away from walls and ceilings, protected from direct sunlight and spaced to permit ventilation, cleaning and inspection (12.23). Products needing specific handling, such as controlled temperature or humidity, are segregated (12.4). Hazardous and flammable items, pressurized gases and narcotics go in a dedicated area with additional safety and security (12.28). Stock is rotated by first-expired, first-out (FEFO): the stock with the earliest expiry is distributed or used before identical stock with a later expiry (12.30). Broken or damaged items are withdrawn from usable stock and separated (12.32).
Site controls
The guidance also expects security and controlled access (12.3), a pest control programme against birds, rodents and insects (12.8), no food, drink or smoking where products are stored or handled (12.9), and a written fire-control procedure with detection and firefighting equipment serviced regularly (12.33).
Storage conditions: what the label terms mean
Clause 12.34 says products are stored in compliance with their labelling and the manufacturer’s information. WHO Appendix 1 (Table A7.1) gives recommended numeric limits for descriptive label terms, so a warehouse and a supplier read the same words the same way.
| Label description | WHO recommended limits |
|---|---|
| Store at controlled room temperature | 15 to 25 °C |
| Store in a cold or cool place | 8 to 15 °C |
| Store in a refrigerator | 5 ± 3 °C |
| Store in a freezer | −20 ± 5 °C |
| Store in deep freezer | −70 ± 10 °C |
| Store in a dry place / Protect from moisture | No more than 60% relative humidity |
| Store under ambient conditions | Well-ventilated premises, 15 to 30 °C, no more than 60% relative humidity, extraneous odours and intense light excluded |
The same appendix says statements such as “store at ambient conditions” should be avoided and that manufacturers should give actual limits where possible, for example “store below 25 °C”.
What records show a warehouse is controlled
Under the WHO guidance, a warehouse is expected to be able to show the following. This checklist is arranged from the clauses above; it is not a certification test.
| Evidence | What the guidance says | Clause |
|---|---|---|
| Temperature mapping | Mapping studies of storage areas, refrigerators and freezers, with humidity where appropriate | 12.36 |
| Monitoring records | Monitoring at regular intervals, records reviewed, monitoring equipment calibrated | 12.37 |
| HVAC | Qualified and maintained | 12.35 |
| Stock records | Updated after each operation, with periodic reconciliation; discrepancies investigated for root cause and corrective and preventive action | 13.1, 13.2 |
| Expiry control | Regular checks for items near expiry; FEFO rotation | 13.4, 12.30 |
| Release authorization | Quarantined goods held until an authorized release | 12.17 |
| Fire and pest programmes | Written fire-control procedure; pest control programme | 12.33, 12.8 |
Where it matters for labs and clinics
For a laboratory or clinic, a product’s stored condition is part of what is delivered. A temperature drift in transit or storage is handled as an event, as described in temperature excursion, and monitoring design is covered in temperature monitoring systems. Cold storage verification is covered in the freezer and cold room temperature mapping protocol guide, and long-distance cold storage in pharma cold chain logistics. For the purchasing side, see hospital supply chain and the fill rate measure, which are separate from the storage facility itself.
Common misunderstandings
- “Ambient” is not a specification. WHO defines it as 15 to 30 °C with humidity and light limits, yet advises against the wording. The label’s stated limits govern (12.34).
- Guidance is not the same as law. WHO Annex 7 is a guideline; legal force depends on national and regional legislation.
- The US warehousing rule is not a device rule. 21 CFR 211.142 applies to drug products.
- A warehouse is not only shelving. The guidance treats receiving, quarantine, release, records, security, pest and fire control as parts of storage.
FAQ
What is a medical warehouse?
A facility for receiving, storing, picking, packing and dispatching medical products under controlled conditions. WHO TRS 1025 Annex 7 describes the premises, zones and records such a facility is expected to have.
What is a medical supply warehouse?
The same kind of facility where the stock is medical supplies and devices. WHO’s definition of medical products includes medical devices, including in vitro diagnostic devices, alongside medicines and vaccines.
What temperature must medical products be stored at?
The one stated on the product’s label or by its manufacturer (12.34). WHO’s Table A7.1 translates common label phrases into limits, for example 15 to 25 °C for controlled room temperature and 5 ± 3 °C for a refrigerator.
Sources
- WHO Technical Report Series No. 1025, 2020, Annex 7, “Good storage and distribution practices for medical products”: WHO TRS 1025 Annex 7 (who.int) (checked 2026-10-30).
- 21 CFR 211.142, Warehousing procedures: law.cornell.edu (checked 2026-10-30).
- FDA, Quality Management System Regulation: fda.gov (checked 2026-10-30).
