Industry · Canada

Pharmaceutical and medical
device warehousing.

Licensing, temperature mapping, excursion procedure, and lot traceability. The four things a pharma warehouse requirement lives or dies on, and none of them appear on a rate card.

2-8°C
Cold chain band
15-25°C
Controlled room temperature
Mapped
Storage qualification, seasonal
Lot + expiry
Traceability to consignee

Storing and distributing drugs in Canada is a licensed activity. A third party that holds finished drug product on your behalf generally needs a Drug Establishment Licence covering the applicable activity, with the building itself listed on that licence, and the site is inspected against Health Canada good manufacturing practice expectations for storage and distribution. Medical devices run a parallel track through a Medical Device Establishment Licence, with its own mandatory procedures for complaint handling, recall, and distribution records.

Everything else follows from temperature. Canadian guidance on temperature control for drug products during storage and transportation sets the operational bar: storage areas are mapped rather than assumed, monitored continuously rather than spot-checked, alarmed with an escalation path that works at three in the morning, and governed by a written excursion procedure that says exactly what happens to product when the band is breached and who makes the release decision.

The third pillar is traceability. A recall does not ask how well the warehouse ran, it asks which consignees received lot number X and how fast you can produce that list. Lot and expiry have to be captured at receipt, enforced through FEFO on allocation, and preserved through to the shipping record. An operator that cannot run a mock recall against your lot structure cannot support your product.

The compliance stack a pharma requirement has to clear

These are the items to confirm in writing during the RFP rather than discover during a site visit. Each one is a gate: a no on any line ends the conversation for finished drug product.

Establishment licence, correct activity, correct building

A Drug Establishment Licence covering the activity being performed, with this address on the licence, for the dosage forms in scope. Medical devices need the corresponding device establishment licence. Ask for the licence number and confirm the site listing.

Temperature mapping and requalification

Mapping studies for each controlled zone under summer and winter conditions, with worst-case locations identified and permanently instrumented. Ask for the last mapping report and the requalification interval, and ask what triggers a remap: new racking, new HVAC, layout change.

Continuous monitoring, calibration, and alarm escalation

Calibrated probes with current certificates, continuous recording, alarms routed to a monitored escalation path outside business hours, and a documented response time. Backup power and redundant refrigeration on cold rooms, because a generator that has never been load-tested is decoration.

Written excursion procedure

What happens when the band is breached: automatic quarantine, notification timeline to the licence holder, the data package produced, and who holds the disposition decision. The answer must be that you hold it, not the warehouse.

Segregated quarantine, hold, and returns

Physically distinct and access-controlled locations for quarantine, recall hold, rejected goods, and returns pending disposition, with WMS statuses that block allocation rather than merely warn.

Recall capability, proven

Lot and expiry captured at receipt, FEFO enforced on allocation, and a documented mock recall with a stated completion time. Ask for the last mock recall record and the elapsed time on it.

Controlled substances, where applicable

Controlled drugs carry separate federal authorization, secured vault storage, dual control, perpetual inventory, and mandatory loss and theft reporting. Most 3PLs are not authorized. Confirm before assuming.

What to specify when you scope the requirement

  • Zones by band, with volumes. State the pallet positions needed in each temperature band separately: frozen, 2 to 8 degrees, controlled room temperature, and ambient. Aggregated volume produces a quote against the cheapest band and a shortfall on the expensive one, and cold capacity cannot be conjured mid-program.
  • The excursion decision rights. Write into the requirement that product is quarantined automatically on excursion and that disposition sits with the licence holder. Operators differ on this, and discovering the difference during an actual excursion is expensive.
  • Recall performance as a measurable target. Specify the elapsed time from recall notice to a complete consignee list by lot, and require evidence from a real mock recall. Adjectives about recall readiness are worthless; a timestamped exercise record is not.
  • Data integrity and system access. Monitoring data and inventory records are part of your regulatory file. Specify retention periods, audit-trail requirements, read access for your quality team, and what you receive on exit. Getting your own temperature history out of a departing provider should not be a negotiation.
  • Audit rights and quality agreement. A quality agreement separate from the commercial contract, defining responsibilities on both sides, plus the right to audit on notice and to be present for regulatory inspections that touch your product.

What it costs

Licensed pharmaceutical storage carries a premium over general cold and ambient warehousing because of the qualification, monitoring, and quality-system overhead behind it. That premium is program-specific. The underlying network bands below are the floor it builds from, current as of Q2 2026.

Line item2026 rangeUnit
Refrigerated storage, 2 to 8 degrees band$22 – $48per pallet / month
Ambient and controlled room temperature storage$12 – $40per pallet / month
Temperature-controlled handling, in or out$10 – $25per pallet, per move
Pick, pack and ship, first unit$2.50 – $7.00per order
Licensed and qualified pharma spaceQuoted per requirementpremium over the bands above, program-specific

Warehouse Bridge network data, current as of Q2 2026, for general refrigerated and ambient capacity. Licensed and qualified pharmaceutical space is quoted per requirement. Full city-by-city tables are in the Canadian Warehouse Market Report, and the 3PL cost calculator models a market-specific figure.

Five questions that separate operators

Ask these in the RFP rather than at the site visit. The answers narrow a shortlist faster than any rate comparison, and they are all verifiable.

  1. What is your establishment licence number, and is this building listed on it for these dosage forms?

    The gating question. A licence at another site does not cover this one.

  2. Show me your last temperature mapping report and the requalification schedule.

    A mapping study that cannot be produced in the meeting has not been read recently, if it exists.

  3. Walk me through your last real excursion, start to finish.

    Every operator has had one. The useful signal is how fast it was detected, who was called, and what happened to the product.

  4. What was the elapsed time on your last mock recall?

    A number with a date behind it, or the recall plan is theoretical.

  5. Who holds disposition authority on quarantined product?

    If the answer is anyone other than the licence holder, the quality agreement needs rewriting before anything ships.

Related guides

Procurement templates: the 3PL RFP template puts the compliance questions above into a requirements sheet vendors respond to line by line.

Frequently asked questions

Does a 3PL need a licence to store pharmaceuticals in Canada?

Generally yes. A third party storing or distributing finished drug product in Canada needs a Drug Establishment Licence covering the relevant activity, with the specific building listed on that licence, and the site is subject to Health Canada inspection against good manufacturing practice expectations for storage and distribution. Medical devices require the corresponding medical device establishment licence, with mandatory procedures for complaints, recalls, and distribution records. Confirm the licence number and the site listing before a requirement goes any further.

What is GDP compliance in a Canadian warehouse?

Good distribution practice in the Canadian context centres on temperature control guidance for drug products during storage and transportation. Operationally it means storage zones are mapped under seasonal extremes rather than assumed, monitored continuously with calibrated instruments, alarmed with an escalation path that functions outside business hours, and governed by a written excursion procedure. It also means qualified equipment, documented training, change control, and records that would survive an inspection.

What happens when a temperature excursion occurs?

The correct sequence is automatic quarantine of the affected product, notification to the licence holder inside a defined window, and a data package showing the duration, magnitude, and location of the excursion along with the product exposed. Disposition, meaning release or reject, belongs to the licence holder, not the warehouse. Write that decision right into the quality agreement, because operators differ on it and an actual excursion is the wrong moment to find out.

How fast should a pharma 3PL complete a recall?

Fast enough to produce a complete list of consignees for a given lot within the window your recall procedure commits to, which is why the requirement should state an elapsed-time target rather than asking whether the provider is recall-capable. Ask for the record of the last mock recall exercise, including the date and the measured completion time. Lot and expiry capture at receipt and enforced FEFO allocation are the prerequisites that make that number achievable.

Can a 3PL store controlled substances?

Only with separate federal authorization. Controlled drugs and narcotics require their own authorization, secured vault storage, dual control on access, perpetual inventory reconciliation, and mandatory reporting of loss or theft. Most third-party logistics providers do not hold this authorization even when they hold a drug establishment licence, so it has to be confirmed explicitly rather than assumed from the presence of a pharma programme.

Scope the requirement with someone who has run one

Warehouse Bridge operates no warehouse of its own. There is no building we need to fill, so the operator that fits the specification wins the work. For a pharmaceutical & medical device requirement, the useful first conversation is about licence scope, compliance profile, and volume, before any building is on the table.

Call (289) 907-3794 or email solutions@warehousebridge.ca. Program structures and thresholds are set out on the enterprise page.

This page is operational guidance for scoping a warehouse requirement, not regulatory advice. Licensing obligations and good practice expectations should be confirmed with Health Canada and your own quality and regulatory function.

Scope a pharmaceutical & medical device requirement

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