Material Quarantine

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated December 2025 • Receiving, Quality Hold & Release Control • Warehouse, QA, Manufacturing, Regulatory

Material quarantine is the controlled state where a material is physically and systemically prevented from use until defined verification steps are completed and a formal disposition is recorded. It is the practical bridge between Goods Receipt and authorized use in production: materials arrive, identities and documents are checked, risk-based tests or reviews are performed, and only then can the material be released. In regulated manufacturing, quarantine is not “put it over there.” It is an enforceable combination of status, segregation, and evidence that ensures the right lot (and only the right lot) can be picked, weighed, kitted, or consumed.

Quarantine exists because most supply-chain failures are invisible at the dock. A pallet can look perfect and still be wrong: mislabeled, contaminated, out of spec, outside temperature limits, missing required documentation, or substituted without notice. Once a questionable lot is consumed, the cost of correction multiplies: batch holds, investigation time, rework, scrap, customer complaints, and recall exposure. A quarantine program is how you keep uncertainty upstream, where it is cheapest to resolve, and how you create defensible evidence that materials were controlled before use.

“Quarantine is a speed feature: you either block errors at receiving, or you chase them through production.”

1) What “Quarantine” Means (and What It Does Not)

Quarantine means “not available for use.” That seems obvious, but most control failures happen when quarantine is treated as a convenience rather than a governed state. A quarantined lot must be blocked in the system so it cannot be allocated, picked, kitted, or issued to a batch. It must also be controlled physically so the warehouse cannot “accidentally” pull it during a rush. The governing principle is: if a lot is in quarantine, your normal execution flows should not be able to consume it without an explicit, traceable override and documented rationale.

Quarantine is also different from “on hold,” although many organizations use the terms interchangeably. In a disciplined system, quarantine is a default state for newly received or unverified material, while hold is an escalated status triggered by a suspected issue (missing docs, damage, temperature excursion, investigation open, supplier alert). Both statuses block use, but “hold” typically implies a stronger reason, additional controls, and a clear disposition path.

2) Why Quarantine Exists in Regulated Operations

Quarantine exists because regulated manufacturing is not allowed to rely on hope. If your product is subject to frameworks such as 21 CFR Part 117, 21 CFR Part 111, 21 CFR Part 211, or quality system standards such as ISO 13485, you must demonstrate that only approved and verified inputs were used and that the decision chain is documented. Quarantine is how you prove that you did not “accept” material into production implicitly.

It also supports basic operational truth: most inbound variability is upstream, and the dock is your last cheap chance to stop it. Once materials are staged, weighed, or mixed, the cost of correction spikes and the investigation complexity increases. Quarantine is how you keep risk at the boundary of the facility instead of letting it propagate into multiple batches.

3) The Three Pillars: System Status, Physical Segregation, and Evidence

A quarantine program fails if it relies on only one control. The minimum defensible structure includes three layers that reinforce each other:

• System status control: the lot is assigned a non-usable status in the WMS so it cannot be picked or consumed.
• Physical segregation: the lot is stored in a designated quarantine zone (or segregated cage/area) and clearly labeled so humans do not improvise.
• Evidence and disposition: the verification steps are recorded (documents, tests, checks) and the final release decision is documented with attribution and timestamps.

When these three pillars are present, quarantine becomes enforceable. When one is missing, quarantine becomes a suggestion.

4) Common Triggers for Quarantine

Some organizations quarantine everything by default until verified; others use risk-based logic. In practice, most operations use both: a default quarantine on receipt, then rules to keep or escalate quarantine based on triggers such as:

• New receipt: newly received lots are quarantined until basic checks and required documentation are complete.
• Missing or inconsistent documents: missing CoA, mismatched item identity, missing allergen declarations, incomplete SDS, or incomplete shipment paperwork.
• Damage or tamper evidence: broken seals, crushed packaging, wet pallets, compromised liners, or evidence of rework/relabeling.
• Temperature issues: broken cold chain, temperature excursion, unknown transit conditions, or missing temperature log where required.
• Supplier performance signals: supplier alert, recent CoA discrepancies, repeated rejections, or active supplier CAPA.
• Internal events: traceability concern, labeling issue, contamination suspicion, mix-up risk, or an investigation that implicates the lot.

Triggers should be explicit and teachable. If the warehouse has to guess what to quarantine, your program will drift under pressure.

5) Receiving Workflow: Where Quarantine Starts

Quarantine is most effective when it begins at the same moment the lot becomes “known” to your system. A typical defensible receiving sequence looks like this:

• 1) Identify: scan or enter supplier item/lot identifiers and match them to your internal item master and approved supplier rules.
• 2) Capture documents: CoA, SDS, allergen statement, bill of lading, temperature data (if applicable).
• 3) Visual inspection: packaging integrity, seal checks, labeling correctness, and any transport damage.
• 4) Assign status: default to quarantine, with risk-based rules to escalate to hold when needed.
• 5) Segregate location: direct put-away into quarantine zone using directed put-away and defined bin/zone topology.
• 6) Initiate verification: sampling plan, lab request, CoA verification rules, and review assignments.

The point is not bureaucracy. The point is to create a repeatable control boundary that blocks use until the facility can defend the lot as acceptable.

6) What Gets Verified During Quarantine

Verification during quarantine should be risk-based and aligned to the material type. Typical verification categories include:

• Identity verification: confirm that the lot is the intended material, not a substitution or mislabel (see Material Identity Confirmation and Identity Testing).
• Specification conformance: confirm key attributes meet defined acceptance criteria; verify units and methods align with your specs.
• CoA review and verification: review supplier CoA and apply your verification strategy (see CoA and Supplier Verification of CoAs).
• Allergen/hazard status: confirm allergen declarations, segregation requirements, and hazard notes (see Allergen Control and SDS).
• Condition checks: temperature acceptance, packaging integrity, seal verification, and storage conditions.
• Traceability readiness: lot code readability and capture, label format compliance, and ability to link supplier lot to internal lot for genealogy.

Quarantine should not be “everything for everyone.” It should be a controlled holding pattern while the facility completes the specific verification steps that matter for that input.

7) Quarantine Locations, Segregation, and Warehouse Design

Physical segregation is where most programs fail, because warehouse space is always under pressure. A defensible quarantine design usually includes:

• A defined quarantine zone: clearly marked locations that are treated as non-usable inventory. The system should not allow normal picking from this zone.
• Clear labeling: quarantine tags or labels with lot ID, status, and reason (e.g., “Awaiting CoA,” “Awaiting Lab Results,” “Hold – Investigation”).
• Controlled access where needed: cages/locked areas for high-risk inputs, controlled substances, allergens, or high-value items.
• Segregation by hazard class: if you handle allergens, incompatible chemicals, or high-risk materials, quarantine storage must respect segregation rules (see Incompatible Chemical Segregation for chemical operations).

Quarantine zones should also be compatible with flow. If quarantine is physically inconvenient, people will work around it. Good design makes compliance the path of least resistance.

8) Status Transitions: Quarantine, Hold, Released, Rejected

Quarantine only works when status changes are controlled and traceable. A practical status model includes:

• Quarantine: awaiting verification; blocked from use.
• Hold: suspected problem or investigation; blocked from use; often includes additional restrictions and escalation.
• Released: verified and approved for use; may still be subject to FEFO/FIFO and segregation controls.
• Rejected: not acceptable; blocked from use; routed to return, disposal, or MRB disposition.

Status transitions should be tied to roles and approvals. If anyone can release quarantine with no evidence, quarantine becomes meaningless. That is why governance elements such as user access management and audit trails matter, even for “warehouse” activities.

9) When Quarantine Becomes an Investigation

If verification fails, quarantine is no longer a passive wait state. It becomes part of an active quality event. Common escalation paths include:

• Nonconformance: log the issue in Nonconformance Management and create an NCMR.
• Deviation: if the issue implicates process or handling (e.g., temperature excursion due to internal storage failure), escalate through Deviation Management.
• Disposition via MRB: route the lot to MRB for disposition decisions (use as-is, rework, return, scrap) with documented rationale.
• Corrective action: repeated supplier issues may trigger CAPA and supplier corrective action requests (e.g., SCAR).

Quarantine is often the first place quality signals appear. A strong program uses that fact: it treats quarantine outcomes as upstream leading indicators, not just warehouse friction.

10) Traceability Linkage: Quarantine Must Preserve Genealogy

One of quarantine’s most underestimated functions is protecting traceability. When a lot is quarantined, you must ensure that the lot identity remains intact and traceable, and that any sampling, repacking, or relabeling does not break genealogy. Best practice is to capture supplier lot and internal lot linkage at receipt, then maintain that linkage through movements (Batch-to-Bin Traceability) and eventual consumption into batches (Batch Genealogy).

If a quarantined lot is relabeled, split, sampled, or repacked, the system must record the transformation events and preserve traceability. Otherwise, quarantine can accidentally create blind spots—exactly the opposite of its purpose.

11) Shelf Life, FEFO/FIFO, and Quarantine Aging

Quarantine interacts directly with shelf life controls. If you quarantine a perishable or time-sensitive material too long, you can create waste or force late-stage substitutions. That does not mean you should rush release; it means your process must be designed to complete verification within predictable lead times and to prioritize time-critical lots.

Once released, inventory should flow according to FEFO (first-expire-first-out) or FIFO as appropriate. Quarantine should not break that logic. The system should know the expiry/retire date even while the lot is quarantined so planners can anticipate whether a lot will still be usable when it clears verification.

12) Temperature-Controlled and High-Risk Storage

Temperature-controlled materials require special quarantine controls because the “condition of storage” is part of the acceptance decision. Quarantine for cold chain items should ensure:

• Immediate placement in controlled temperature locations: quarantine should not mean “sitting on the dock.”
• Evidence capture: temperature loggers or transit data where required, plus internal storage temperature verification.
• Defined response to excursions: quarantine should trigger investigation and disposition rules rather than ad-hoc decisions.

For high-risk materials (allergens, hazardous chemicals, controlled substances, high-value items), quarantine often requires stricter segregation, controlled access, and more explicit release approvals. The stricter controls are not about distrust; they are about consequence. When consequence is high, controls must be unambiguous.

13) Common Failure Modes (How Quarantine Breaks in Real Life)

Most quarantine programs fail for predictable reasons:

• System allows picking from quarantine: the status exists, but allocation rules ignore it, so the warehouse can still pull the lot under pressure.
• Physical segregation is weak: quarantine is “a row,” not a controlled zone, so materials drift into available storage.
• Labels are inconsistent: humans can’t tell the difference between quarantined and released at a glance.
• Release criteria are unclear: people release based on intuition rather than defined evidence steps.
• Overrides are informal: supervisors allow use “just this once” without controlled documentation, creating hidden risk and audit exposure.
• Verification is slow: quarantine becomes a parking lot, forcing planners to substitute and eroding confidence in controls.

The fix is not more training alone. The fix is redesigning controls so compliance is enforced by the system and supported by the facility layout.

14) Practical Blueprint: A Quarantine SOP That Works

A quarantine SOP should be short enough to execute and strict enough to prevent drift. A practical structure looks like:

• Scope: what materials are covered (raw materials, packaging, components, returns, rework) and when quarantine applies.
• Status rules: definitions of quarantine, hold, released, rejected; who can change each status.
• Physical controls: quarantine zone locations, labeling rules, access restrictions, and movement rules.
• Verification steps: required documents, CoA review rules, sampling plans, identity testing requirements, and timelines.
• Disposition paths: how failures are recorded (NCMR, MRB), and what evidence is required for each disposition.
• Exceptions: controlled emergency release rules if allowed, with documented justification and retrospective verification requirements.
• Records: where evidence is stored, retention expectations, and how data integrity and audit trail requirements are met.

If your quarantine SOP is longer than your organization can execute, your facility will invent an informal version. That informal version will eventually be tested by an audit, a customer issue, or a recall event.

15) How This Fits with V5 by SG Systems Global

V5 WMS + Receiving. With WMS controls, quarantine becomes enforceable: lots can be assigned quarantine/hold status at receipt, directed into quarantine zones using bin/zone topology, and blocked from picking and kitting until release is recorded. Movement and status events remain traceable for genealogy and rapid response.

V5 QMS. In V5 QMS, verification evidence (CoA review, supplier verification results, sampling outcomes, temperature checks) can be linked to the lot record and governed under document control and audit trail expectations. Failures route into nonconformance, NCMR/MRB workflows, and CAPA when patterns emerge.

Bottom line: V5 lets quarantine operate as a closed-loop control: receive → quarantine → verify → disposition → release, with full traceability and attributable evidence, rather than a warehouse side process that lives in spreadsheets and emails.

16) FAQ

Q1. Should everything be quarantined at receiving?
Many regulated operations default to quarantine at receipt and then release based on verification. Others use risk-based rules (some items release on document review only). The key is consistency: whatever rule you choose must be enforceable and supported by evidence.

Q2. What’s the difference between quarantine and hold?
Quarantine is typically a default “awaiting verification” status. Hold is usually an escalated status tied to a suspected issue or an open investigation. Both block use, but hold typically requires stronger controls and a clearer disposition trail.

Q3. What evidence is required to release a quarantined lot?
It depends on the material and risk tier. Common requirements include receiving inspection completion, required documents (CoA/SDS/declarations), CoA review or verification outcomes, sampling/testing results where applicable, and a documented release decision.

Q4. Can production ever use quarantined material in an emergency?
If your system allows emergency release, it must be a controlled exception: documented justification, defined approvals, traceable override, and retrospective verification steps. Uncontrolled “just this once” usage is how quarantine programs collapse.

Q5. What happens when a lot fails verification?
It should be routed into nonconformance management with an NCMR, then dispositioned via MRB (return, scrap, rework, or controlled use if justified), with full documentation and traceability.

Q6. How does quarantine support traceability?
Quarantine ensures supplier lot identity is captured and preserved before use. Lot linkage and movement controls maintain genealogy so downstream batches can be traced quickly if issues arise.

Related Reading
• Receiving & Warehouse: Goods Receipt | WMS | Bin & Zone Topology | Directed Put-Away
• Hold, Release & Disposition: Hold/Release | Nonconformance Management | NCMR | MRB | CAPA
• Evidence & Integrity: CoA | Supplier Verification of CoAs | Document Control | Audit Trail (GxP) | Data Integrity
• Traceability: Batch-to-Bin Traceability | Batch Genealogy | End-to-End Genealogy | Upstream Traceability