Release Status (Hold/Release) – QA Disposition

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

Updated October 2025 • Product Status Governance & Final Disposition • QA, QC, Manufacturing, Warehouse

Release Status is the formal control that determines whether material can move, be processed, or be shipped. In practice, organizations operate a small set of explicit states—most commonly Hold and Released—with variations such as Quarantine, Rejected, Conditional, or Restricted Use. These states are not stickers; they are system‑enforced permissions that block picks, weighments, production issues, and shipments until QA (and where appropriate QC) completes the evidence review and documents a disposition. From receiving through manufacturing to finished goods, status changes are recorded via compliant audit trails and e‑signatures to meet QMSR, 21 CFR Part 11, and Annex 11.

“Status is a gate, not a label. If the system doesn’t block the action, you don’t have control.”

1) What “Release Status” Means—and Where It Applies

Status exists at multiple levels: item/lot, serial, batch, work order, pallet/case, and sometimes shipment. A raw material lot may be on Hold while its COA is verified; a batch in the MES may be on Hold pending IPC review; a finished SKU may be on Hold until QA performs finished‑goods release or lot release. The WMS enforces pick/putaway blocks; the MES enforces issue/execute blocks; the QMS stores the decision rationale, signatures, and attachments under Document Control.

2) The Canonical States

• Quarantine (Hold): Default at goods receipt, after deviations, or when evidence is incomplete. Segregation and blocked use are required. See Quarantine – Quality Hold Status.
• Released: All acceptance criteria met; material is available to issue, pick, or ship per master data rules. See Hold/Release.
• Rejected: Material fails criteria; disposition is scrap, return, or MRB‑directed downgrade.
• Conditional/Restricted: Limited‑use release (e.g., internal rework feedstock) with explicit constraints and labels; never for customer shipment without QA override and records.
• MRB Required: Status pending formal MRB decision after an NCMR/NCR.

3) Triggers for Status Changes—From ASN to Audit Trail

Common transitions include: (1) Receiving → Quarantine upon ASN arrival and dock‑to‑stock check; (2) Quarantine → Released after inspection/sampling, COA verification, and label confirmation; (3) In‑Process Hold triggered by IPC or SPC violations, calibration status failure, or line‑clearance issues; (4) Batch → Released after complete, reviewed eBMR; (5) Finished Goods → Released after label verification and, where applicable, serialization and EPCIS event checks. Every transition requires a reason, user, timestamp, and audit trail entry.

4) Receiving & Initial Status—Contain First, Prove Later

At goods receipt, the safest default is Hold. The WMS directs putaway to a designated Quarantine zone and blocks issue/pick until QA changes status. Use barcode validation to capture GTIN, lot, and expiry; reconcile the shipment against the ASN/EDI. QA reviews COAs, executes incoming inspection per sampling plans, and documents any NCMR.

5) In‑Process Holds—Interlocks That Prevent Bad Product

During manufacture, MES interlocks enforce status automatically. Examples: failed scale verification halts weighing; expired or blocked lots cannot be issued; line clearance failures stop step start; SPC breaches trigger Hold pending QA review; a device with out‑of‑date calibration status blocks execution. Each interlock changes the batch or step to a Hold state and logs the reason in the eBMR.

6) Finished‑Goods Release—Evidence Before Availability

Final disposition depends on complete records and correct identity. QA confirms the eBMR is complete and signed, verifies label content via labeling control, runs label verification scans, and, for serialized products, checks unique identifiers and EPCIS events. Only then is Finished Goods Release granted and the WMS stock moved from Hold to Released, enabling order picking and pack & ship.

7) Documentation, Signatures & Data Integrity

Release is ultimately a documented decision. The basis for release—COAs, inspection data, test results, deviation closures, label proofs—must be attached to the batch, lot, or SKU under Document Control. Status changes require secure e‑signatures per Part 11/Annex 11, and the system must keep unalterable audit trails. Adhere to ALCOA principles from Data Integrity to ensure the release rationale is contemporaneous, attributable, and accurate.

8) Segregation & Physical Controls in the Warehouse

Physical reality must match system status. Use bin/zone topology to allocate Quarantine aisles and Released stock zones. Configure the WMS to block picks from Quarantine and to require directed putaway when status changes. Apply clear visual cues on pallets and racks, but remember: physical tags support the system—they never replace it. Reconcile on‑hand counts via cycle counting and correct any status/bin mismatches immediately to protect inventory accuracy.

9) Labeling & Identity—Status Starts with the Right Product

Incorrect or incomplete labels are a frequent cause of Hold. Verify artwork versions via labeling control and scan variable data per label verification. For pallets and cases, scan SSCC; for units, scan serials and lot/expiry. Status cannot be correct if identity is uncertain—tie these checks to the release workflow and the eBMR.

10) Deviations, MRB & Disposition

When acceptance criteria fail, raise an NCMR/NCR and route to MRB. MRB outcomes—release as is, rework, downgrade, or scrap—determine the status path. If systemic, open CAPA and verify effectiveness by monitoring reduced Holds for the same cause. Every MRB decision should update status instantly in WMS/MES, preventing accidental use while paperwork catches up.

11) Change Control, Re‑Testing & Re‑Release

Sometimes a Hold results from a change: new label templates, updated test methods, software upgrades, or recipe logic adjustments. Route these through Management of Change (MOC). If the change corrects the issue, execute targeted testing and document a re‑release rationale in the QMS. Keep the chain intact: original Hold reason → change → evidence of fix → re‑release signature. Align periodic reviews with QMSR expectations to ensure status logic remains fit for purpose.

12) Metrics—Proving Control with Numbers

• Hold backlog and aging by SKU/lot and by reason code.
• Release cycle time (receipt to QA disposition; batch complete to finished‑goods release).
• False‑positive interlocks vs. true defects (tune your SPC and device checks accordingly).
• Pick attempts blocked from Quarantine—should trend down with training.
• Label/identity Holds as a % of all Holds—feed to labeling control improvements.
• MRB closure lead time and CAPA effectiveness.
• Downstream impact on OTIF and lead time as KPIs.

13) Common Pitfalls & How to Avoid Them

• “Sticker‑only” control: Physical tags with no system block. Fix: enforce status in WMS/MES; stickers become secondary.
• Manual overrides without reason: Users flip status to ship. Fix: require reason codes, e‑signatures, and audit trails for overrides.
• Stale Holds: Aged Quarantine lots clutter space. Fix: dashboards and SLA escalation for aging Holds.
• Identity blind spots: Missing lot/serial scans. Fix: mandatory barcode validation at every gate; verify SSCC for pallets.
• Uncontrolled rework: Product “fixed” off‑system. Fix: route rework via MES with updated eBMR and QA re‑release.
• Labeling drift: Artwork or variable data errors. Fix: close the loop with labeling control and scan‑back checks.
• Time‑sync issues: Mixed device clocks break data integrity. Fix: enforce centralized time across clients, servers, and instruments.

14) How This Fits with V5 by SG Systems Global

V5 Solution Overview. The V5 platform is built around status governance. Configuration is versioned, evidence is attributable, and cross‑module interlocks (identity, status, signatures) are testable and reportable—ideal for robust Hold/Release control.

V5 QMS. Within the V5 QMS, QA dispositions live with their rationale, attachments, and signatures under Document Control. Deviations, MRB decisions, and CAPA are linked directly to the held lot or batch, ensuring status changes are always evidence‑backed.

V5 MES. The V5 MES enforces release status at issue and step execution: expired or held lots cannot be used; IPC/SPC breaches trigger automatic Holds with audit trails; rework is captured into the eBMR with electronic sign‑off for re‑release.

V5 WMS. The V5 WMS implements zone‑based Quarantine, directed putaway, and pick blocking. Label scans (GTIN, lot, expiry, serial, SSCC) and label verification are embedded so only Released inventory can flow to outbound.

Bottom line: V5 makes status a first‑class control—whether material is inbound, in process, or outbound, the same digital gates protect customers and keep audits straightforward.

15) FAQ

Q1. What’s the difference between Lot Release and Finished‑Goods Release?
Lot Release applies to a specific lot/batch meeting its acceptance criteria; Finished‑Goods Release confirms the shippable SKU (often across multiple lots/labels) is compliant for sale and labeling, enabling customer shipment.

Q2. Who owns the disposition from Hold to Release?
QA owns final disposition and signatures. QC owns the test evidence; operations own execution, segregation, and status obedience in WMS/MES.

Q3. Can we use “Conditional Release” to ship while tests finish?
Only under a documented risk assessment and SOP with explicit constraints, and never where regulation prohibits. Conditional status must still block any unauthorized use and be fully traceable under Document Control.

Q4. How do we prevent accidental picks from Quarantine?
Use Quarantine zones, pick blocking in the WMS, and handheld scan prompts that display status. Train to “scan first, move second.” Monitor blocked‑pick attempts as a KPI.

Q5. What evidence is usually required for Release?
COA match, sampling/inspection results, QC test reports, label proofs and scan‑backs, deviation closures, and a signed disposition in the eBMR or lot file with audit trails.

Q6. How do status and serialization interact?
Serial states must mirror material status: held serials cannot be picked or shipped. On release, publish correct events (e.g., via EPCIS) to keep channel records aligned.

Q7. What triggers an In‑Process Hold in MES?
Typical triggers are IPC limit breaches, device calibration expiry, failed line clearance, or label mismatch. The system should halt the step, record the reason, and require QA release to continue.

Q8. How do we re‑release after rework?
Execute rework under MES with evidence into the eBMR, retest as required, then QA signs a re‑release disposition. Keep the entire chain traceable from original Hold to final Release.

Related Reading
• Status & Disposition: Hold/Release | Quarantine | Lot Release | Finished‑Goods Release
• Records & Integrity: Audit Trail (GxP) | Data Integrity | Document Control | 21 CFR Part 11 | Annex 11
• Execution Systems: MES | WMS | eBMR
• Controls & Checks: Incoming Inspection | Sampling Plans | IPC | SPC Limits | Label Verification
• Issues & Change: NCMR | NCR | MRB | CAPA | MOC