Expiration & Shelf-Life Control

Expiration Date & Shelf-Life Control – Preventing Use or Shipment of Out-of-Spec Materials

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

Updated October 2025 • Material & Product Quality • WMS, MES, QMS

Expiration & Shelf-Life Control is the governance of dating attributes—expiry dates, retest dates, and in-use limits—through receipt, storage, manufacturing, testing, labeling, and distribution. It ensures time-dependent quality (potency, sterility, safety) is preserved and that expired or near-expiry stock is quarantined, relabeled, reworked, or destroyed under control. In practice this spans master data (lot dating rules), warehouse logic (FEFO), execution checks in WMS/MES, and governance in QMS for holds and disposition.

“Date math is quality control. If the system can’t prove the clock was respected at every handoff, you’re gambling with compliance and customers.”

1) What It Is

Control of shelf-life means the right dating rule is applied to the right lot at the right step, and that obsolete or expired stock cannot be used or shipped. Key elements include raw-material expiry/retest, in-process timers (e.g., hold time), finished-goods expiry, and in-use periods after opening/prep. Executed records—e.g., pick/issue, weigh/dispense, line clearance, ship confirm—must carry dating checks and be preserved per your Data Retention & Archival policy.

TL;DR: Define dating rules, enforce FEFO and interlocks at pick/issue/ship, quarantine exceptions, and document dispositions—so only conforming lots are used and customers never receive expired product.

2) Regulatory Anchors & Scope

Predicate rules require expiry control and scientifically justified shelf-life. Pharma (21 CFR 210/211) covers stability, retest, and expiry on labels; food/supplements (21 CFR 117/111) require prevention of adulteration and accurate dating; devices (820) manage storage/environment and labeling/UDI. When records are electronic, Part 11 / Annex 11 apply. Shelf-life programs therefore cover:

  • Master data for dating (expiry, retest, in-use) and grace/hold rules by item.
  • Warehouse control (FEFO, quarantine, relabel, destruction with witnesses).
  • Execution checks at weigh/dispense, issue, mix, pack, and ship.
  • Labeling of expiry/retest and storage conditions; UDI/lot where applicable.
  • Review via audit trails, periodic reassessment, and stability feedback.
  • Retention of dating decisions and dispositions for inspection.

3) Lifecycle: From Receipt to Distribution

Creation & numbering. Items receive dating attributes from specs or stability protocols; lots inherit at receipt with supplier CoA checks. Controlled fields for BOM and label masters ensure downstream linkage.

Review & approval. Dating rules and changes follow role-based Approval Workflow; QA confirms scientific justification and alignment with stability and labeling.

Effective dating & training. Effective dates synchronize with inventory updates and training; systems may enforce training gating before enabling new rules.

Distribution & control of copies. Current label templates and pick rules are system-served; printed copies are watermarked with validity windows; obsolete rules are read-only.

Revision & change control. Changes to shelf-life or retest require Change Control with impact to labels, ERP/MES/WMS, and stability files; audit trails capture rationale.

Archival & decommissioning. Retain rule histories, exception logs, and destruction records; validate renderability of dated evidence.

4) Scope & Examples

  • Raw materials: expiry/retest at receipt; storage conditions; partial-container in-use timers.
  • Intermediates: hold-time limits between steps; rework windows.
  • Finished goods: labeled expiry; temperature excursions; market relabel.
  • Warehouse logic: FEFO; near-expiry thresholds; quarantine and relabel flows.
  • Distribution: ship-to constraints by channel/region; returns handling.
  • Master data: date calc methods (DOM, MFG+X months, fixed), rounding rules.

5) Technical Controls for Shelf-Life

  • Identity & access. Unique users; role-based changes to dating rules; no shared accounts.
  • Audit trails. Immutable logs for rule changes, picks, issues, holds, relabels, and ship confirms.
  • Interlocks. Blocks on pick/issue/ship when expiry or near-expiry thresholds are violated.
  • Versioning. Effective/retire states for rules and label templates with runtime enforcement.
  • Label control. Approved templates print expiry/retest and storage conditions; barcode verification.
  • Search & retrieval. Filter by item/lot/expiry window; inspection-ready rendering.
  • Integration. Validated exchange with MES/LIMS/WMS/ERP via the V5 Connect API.

6) Common Failure Modes & How to Avoid Them

  • Manual date math. Operators calculate expiry by hand. Fix: system-calculated dates and barcode checks.
  • Mixed rules. Item uses both expiry and retest inconsistently. Fix: master-data governance and training.
  • Near-expiry shipments. Customer SLAs violated. Fix: FEFO with customer/channel thresholds and hard blocks.
  • Label mismatch. Template not updated after rule change. Fix: Approval Workflow + runtime version checks.
  • Excursion blindness. Temp spikes ignored. Fix: EM integrations and CAPA triggers.
  • Weak destruction control. No witness or chain of custody. Fix: controlled destruction with signatures and attachments.

7) Metrics That Prove Control

  • Expired inventory (value/units) and trend by item/channel.
  • Near-expiry exposure (units within threshold) and prevention rate.
  • FEFO adherence (% picks honoring FEFO vs overrides).
  • Exception cycle time from hold to disposition (median/90th).
  • Label accuracy (expiry/retest correctness) from sampling or complaints.

8) How It Relates to V5

V5 by SG Systems Global enforces shelf-life from dock to customer. In V5 WMS, FEFO and channel thresholds block near-expiry shipments; quarantine and relabel flows are guided and auditable. In V5 MES, weigh/dispense and batch steps check expiry/retest and in-process hold times. V5 QMS controls rule changes, deviations, and destruction with Part 11/Annex 11 audit trails. Analytics trend exposure, FEFO adherence, and complaint signals.

9) FAQ

Q1. Expiry vs Retest—what’s the difference?
Expiry prohibits use beyond the date. Retest permits re-evaluation; if results pass, use may continue under controlled extension.

Q2. Can we ship near-expiry stock?
Only if customer/channel thresholds and remaining shelf-life are met and risk is documented; many programs forbid below X months.

Q3. How are in-use timers handled?
System starts timers on opening/prep and blocks use after timeout; labels and eBMR steps carry the in-use expiry.

Q4. What if stability changes shelf-life mid-market?
Use Change Control to update rules and labels; quarantine impacted lots; inform customers if needed.

Q5. How do we prove FEFO?
Show pick logs with lot dates, FEFO algorithm evidence, and overrides with justification and QA approval.

Related Reading
• Execution & Control: Directed Picking | Dynamic Lot Allocation | Bin / Location Management
• Records & Integrity: Audit Trail (GxP) | Data Integrity | Data Retention & Archival
• Quality System: Approval Workflow | CAPA | Change Control



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