Quarantine – Quality Hold Status

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

Updated October 2025 • Release Control & Material Status • QA, Warehouse, Manufacturing, Laboratory

Quarantine (Quality Hold) is a blocking status that prevents consumption, movement, packing, and shipment of materials until a qualified decision is posted. It is not a banner or a bin color; it is a system-enforced interlock wired into WMS, MES, and LIMS so the plant does not proceed on hope. Quarantine exists to protect customers and compliance: at Goods Receipt, during Incoming Inspection, through in‑process checks, and up to Finished Goods Release. Decisions are recorded with attributable signatures and audit trails under 21 CFR Part 11/Annex 11, and the outcome flips status to Release, Reject, or Rework via controlled Approval Workflow.

“If quarantine doesn’t stop a pick, it isn’t quarantine—it’s décor.”

1) Definition and Purpose

Quarantine is a material status meaning “physically present, not available for use.” It is created automatically by events (receipt of supplier lots, stability/EM excursions, IPC failures) or manually by authorized roles when risk is suspected. It prevents allocation and movement into “Released” zones and stops transactions that would consume or ship the item. Quarantine exists to:

• Enforce evidence‑based Lot Release and Finished Goods Release.
• Contain risk during Nonconformance investigation or supplier issues (NCR/NCMR).
• Prevent expiry or identity‑related errors (FEFO violations, wrong GTIN/label) from reaching customers (FEFO, GS1 GTIN).

2) Where Quarantine Applies

• Receiving & Warehousing: At Goods Receipt, supplier lots default to quarantine pending inspection and lab results; WMS prevents directed putaway into “Released” bins (Bin Location Management).
• Manufacturing (IPC): In the MES, failed IPC holds the batch step and quarantines affected WIP until disposition.
• Laboratory: In LIMS, samples and lots remain in quarantine until results meet spec and QA approves; the decision flows back to WMS/MES.
• Packaging & Labeling: Failed label verification quarantines finished goods and printed media; rework is controlled under NCR/MRB.
• Distribution & Returns: Returns or temperature excursions automatically quarantine received goods for QA inspection; shipping is blocked until release.

3) Status Model and Data Fields

Quarantine must be modeled as normalized status with reason codes and scope. Typical data include:

• Status: Pending, Quarantine, Released, Rework, Rejected.
• Scope: Item, lot, sub‑lot, pallet/tote (SSCC), bin, or entire shipment.
• Reason Codes: Supplier quality, identity mismatch, OOS/OOT, IPC fail, labeling fail, environmental excursion, expiry risk.
• Effective/Set By: Timestamp, user, role; release sign‑off users; all changes recorded in the Audit Trail.
• Attachments: Test results, images, CoA, deviation records, MRB decisions (CoA, MRB).

Do not encode quarantine as free text or bin name. Make it a first‑class field that systems can enforce and report on.

4) Triggers That Must Create Quarantine

• Receiving: New supplier lots; ASN mismatch; missing/invalid CoA; damaged packaging (auto‑open NCR).
• Inspection/Lab: Failed or pending Incoming Inspection or release tests in LIMS (identity, potency, microbiology).
• Manufacturing: Out‑of‑limit IPC (weight, torque, temperature, pH) or equipment out of calibration status.
• Labeling: Label verification non‑reads, wrong GTIN, or artwork mismatch.
• Environmental: EM or cold‑chain excursions; expiry risk or FEFO violation.
• Deviations: Any critical Nonconformance involving identity, mix‑ups, or suspect traceability immediately quarantines impacted scope.

5) Warehouse Behavior Under Quarantine

Under quarantine, the WMS must:

• Block putaway into “Released” zones; direct to Quarantine area with visual cues and access control (Bin Location Management).
• Exclude quarantined lots from Directed Picking, FEFO/FIFO, and wave planning.
• Prevent label printing for quarantined stock; scans should fail with reason code until disposition.
• Allow controlled sampling moves to QA/Lab with chain‑of‑custody and auto‑return to quarantine.
• Capture pick attempts against quarantined stock as blocked events; these are quality KPIs, not nuisances.

For pallets/totes, status must propagate at the container level (SSCC) and down to constituent lots; disposition changes must roll up and reconcile to eliminate mixed‑status containers (SSCC).

6) Manufacturing & eBMR Interlocks

In the MES, quarantine blocks:

• Material Issue: Components with Quarantine/Reject status cannot be kitted or issued; material selection must respect WMS disposition via integration.
• Step Progression: If an IPC result fails or is pending, the eBMR prevents “Next” until QA disposition or authorized rework path is followed.
• Rework: Allowed only per controlled instruction under Document Control; the MES must log the exact path and signatures.

Batch/WIP quarantines must be visible in Lot Genealogy so downstream lots inherit the correct risk posture until cleared.

7) Laboratory & Release Decisions

In LIMS, accessioning and testing drive disposition. Until results are approved, the lot stays quarantined in WMS/MES. On approval, the post disposition message flips status to Released and, for finished goods, attaches the CoA to the lot record. If results fail, the lot moves to Reject or Rework and Nonconformance is opened. All calculations and decisions must be backed by immutable records (Data Integrity).

8) Labeling, Artwork, and Pack‑Ship

Labeling errors are a top quarantine driver. Integrate label verification so non‑reads, wrong GTIN, or template mismatches create instant quarantine on affected stock and printed media. The pack/ship flow must refuse pick/pack for quarantined items, block ASN/EDI confirmations for them, and include their status in outbound visibility (EDI, EPCIS events).

9) Traceability and External Visibility

Quarantine must be traceable across movements and partners. Record status changes in lot/container genealogy and expose events with GS1 keys for trading‑partner correlation (GTIN, SSCC). Where required, publish quarantine/release events as EPCIS “Object Events” with disposition to support recall readiness (GS1 GTIN, SSCC, EPCIS).

10) Compliance Anchors—Records, Signatures, and Time

Quarantine decisions are electronic records subject to Part 11/Annex 11: unique credentials, signature meaning, and secure audit trails. Evidence must be attributable, contemporaneous, and complete (Data Integrity), and retained per policy (Data Retention & Archival). Predicate rules require documented controls (e.g., GMP/cGMP and GDP for storage and distribution conditions).

11) Investigations, MRB, and Durable Change

When quarantine stems from a failure, the process is formal: open Nonconformance (NCR/NCMR), assemble evidence, and route to the MRB for disposition (release with justification, rework, or scrap). Root causes drive corrective action through CAPA and are institutionalized under MOC. These linkages are essential for trend reviews like the APR and ongoing control (CPV).

12) Metrics That Prove Control

• Quarantine Aging: avg/median days by reason code; long tails signal bottlenecks.
• Blocked Attempts: pick/issue/ship blocks per 1,000 transactions—evidence of gates working.
• Time to Disposition: detection → MRB decision → physical status flip.
• Repeat Offenders: suppliers/items with frequent quarantine; drives supplier quality actions.
• Escape Rate: incidents where usage/shipment occurred pre‑disposition (target: zero).
• Impact on Service: release latency vs. order fulfillment; manage via staffing and parallel testing.

Trend by site, product family, supplier, and shift. Feed into APR and CPV for systemic improvements.

13) Implementation Playbook (Forward & Frank)

• Make quarantine binary and enforced: transactions must fail loudly; no soft warnings.
• Wire the two decisive messages: create sample + set QA Hold at trigger; post disposition → flip to Released/Rework/Reject at decision (LIMS ↔ WMS/MES).
• Normalize reasons and scope: standard codes and levels (lot, bin, SSCC) for clean analytics.
• Kill manual workarounds: remove “misc pick” and “free move” abilities for quarantined stock.
• Expose visibility: show quarantine on handhelds, work centers, and planning boards.
• Speed up decisions: pre‑allocate inspection slots, enable parallel testing, and staff QA accordingly.
• Test fail‑intent: in OQ/PQ, prove that expired lots, label mismatches, and pending results block progression.
• Close the loop: every repeat quarantine reason should have a CAPA; update SOPs via MOC.

Bottom line: quarantine is where quality meets physics. If systems can’t stop movement, you don’t have control—you have paperwork.

14) How This Fits with V5 by SG Systems Global

V5 Solution Overview. The V5 platform treats quarantine as a first‑class status shared across modules. Configuration is versioned, decisions are attributable, and status interlocks are testable and reportable—ideal for audit‑ready release control.

V5 WMS. In the V5 WMS, receiving defaults new lots to QA Hold; directed putaway steers to quarantine zones; Directed Picking excludes quarantined stock from FEFO/FIFO; label services refuse printing for held items; blocked pick/ship attempts are logged as control KPIs. SSCC containers inherit quarantine and synchronize on release.

V5 MES. The V5 MES checks disposition at material issue and at each IPC gate; the eBMR blocks progression on pending/fail status and auto‑opens Nonconformance when violations occur.

V5 QMS. Within the V5 QMS, quarantine reasons are standardized; deviations flow to MRB with structured dispositions; corrective actions are tracked in CAPA; SOP updates are governed by MOC. Audit trails, signatures, and retention align with Part 11/Annex 11. Bottom line: V5 turns “Quality Hold” into a plant‑wide interlock that’s felt on the floor and defensible in audits.

15) FAQ

Q1. What’s the difference between “Pending,” “Quarantine,” and “Reject”?
Pending means awaiting evidence; Quarantine means physically blocked until a decision; Reject means not fit for use or shipment and must be scrapped or reworked per SOP/MRB decisions.

Q2. Can operators bypass quarantine for urgent orders?
No. Bypass requires routed Approval Workflow with QA authorization and e‑signatures. The safer path is to accelerate testing and MRB, not to weaken gates.

Q3. How do we sample from quarantined stock?
Use controlled WMS moves to QA/Lab sampling areas with chain‑of‑custody. The source stock remains quarantined until LIMS posts Release back to WMS/MES.

Q4. What documentation is required for release from quarantine?
Approved test results (where applicable), QA review/approval with e‑signature, MRB disposition if needed, and complete audit trail entries. For finished goods, attach the CoA to the lot record.

Q5. How do we show auditors quarantine is effective?
Demonstrate blocked transactions in WMS/MES, show synchronized status in lot genealogy, provide audit‑trail extracts with timestamps and users, and trend metrics like quarantine aging and blocked attempts. Connect repeated causes to CAPA and MOC.

Related Reading
• Release & Decisions: Hold/Release | Lot Release | Finished Goods Release
• Systems & Execution: WMS | MES | LIMS | eBMR
• Identity & Labels: Label Verification | GS1 GTIN | SSCC
• Traceability & Standards: Lot Traceability | EPCIS
• Compliance & Records: 21 CFR Part 11 | Annex 11 | Audit Trail (GxP) | Data Integrity | Data Retention & Archival
• Quality Actions: Deviation / Nonconformance | NCR | NCMR | MRB | CAPA | MOC