Shelf‑Life & Expiry Dating – Use‑By Governance

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

Updated October 2025 • Stability, Labeling & Distribution Control • QA, Manufacturing, Supply Chain

Shelf‑life and expiry dating define how long a product can be stored and used while meeting its approved quality attributes and safety profile. “Use‑by” or “expiry” is the date beyond which product should not be used; for some materials (e.g., APIs), a “re‑test date” may instead permit re‑evaluation before use. Assigning, displaying, and managing these dates is a cross‑functional discipline that spans stability science, controlled labeling, warehouse execution (e.g., FEFO), and quality decision‑making (Hold/Release), all governed under Expiration & Shelf‑Life Control and proven by data integrity.

“A date on a label is a scientific promise: that if you store it right, quality will still be right.”

1) What Shelf‑Life Governance Covers—and What It Does Not

Covers: Determining scientifically justified shelf‑life from stability studies and hold time studies; defining storage conditions (e.g., 2–8 °C, protect from light); assigning and maintaining expiry/use‑by or re‑test dates; printing and verifying labels; enforcing FEFO in warehouse and distribution; managing excursions and decisions through quality status and ultimately Lot Release/Finished Goods Release.

Does not cover: Shelf‑life is not a logistics convenience or a negotiable sales term. It cannot be shortened or extended arbitrarily to fit inventory needs; changes require evidence, assessment, and controlled implementation through MOC with appropriate CAPA where needed.

2) Legal, System, and Data Integrity Anchors

Shelf‑life governance sits within the quality system. Electronic records and signatures must align to 21 CFR Part 11 and, where applicable, Annex 11, with validated software under CSV and immutable audit trails. Sector regulations such as 21 CFR 211 (drugs), 21 CFR 117 (foods), and ISO 13485 (devices) expect justified expiry dating, controlled labeling, and distribution practices that protect quality under GDP. These anchors ensure dates on packs are backed by reconstructable evidence.

3) The Evidence Pack for Expiry Assignment

Expiry assignment is built on a coherent dossier. It begins with product and packaging characterization and a written protocol for stability (real‑time, accelerated where appropriate) that defines lots, pull points, test methods, and acceptance criteria. Methods and equipment must be qualified and in status, with data captured in LIMS and, where exploratory work is performed, reasoned in an ELN. Hold Time Studies justify intermediate storage claims (e.g., bulk hold, in‑process queues). Packaging’s protection (e.g., light/oxygen barrier) and closure integrity are part of the evidence, as are environmental controls and excursion handling. The resulting expiry rationale and labeled storage conditions are version‑controlled under Document Control and referenced in the eBMR.

• Stability design: lots, conditions, time points, and acceptance criteria.
• Analytical fitness: validated/verified methods, instrument status, and calculations.
• Packaging & closure: barrier properties, integrity evidence, and label durability.
• Storage controls: mapped environments, alarms, and excursion procedures.
• Rationale & labeling: use‑by/re‑test date logic and storage statements traceable to evidence.

When assembled and governed correctly, this pack allows anyone to understand why a given date is printed and how to keep it valid through the supply chain.

4) From Development to Printed Expiry—A Standard Path

1) Define risks & hypotheses. Use formulation knowledge and PFMEA to identify degradation pathways and critical storage controls.
2) Execute stability & hold studies. Generate time‑point evidence under defined conditions; capture results in validated systems.
3) Analyze & decide. Trend data, evaluate OOT signals, and set expiry and storage conditions with documented rationale.
4) Author labels & SOPs. Control wording and data tokens under Labeling Control and Document Control.
5) Verify & release. Print variable data, perform Label Verification, then proceed through QA review to Lot Release.
6) Monitor & improve. Feed learnings into PQR and CPV.

If any link is weak—unclear storage statements, unverified variable data, or ungoverned changes—the printed date ceases to be defensible and product risk increases.

5) Handling OOS, OOT, and Deviations Before Dating Decisions

Stability OOS results or OOT trends demand structured investigation from raw data integrity checks to root‑cause analysis and risk assessment. Where impact cannot be bounded, affected lots move under Quarantine or targeted Hold/Release while CAPA is implemented. Changes to expiry or storage statements proceed only via MOC with updated labeling and system configuration.

6) Contract Manufacturing, Importation & Distribution Networks

Expiry governance extends to partners and lanes. Quality agreements should specify stability responsibilities, storage definitions, alarm/notification expectations, and data formats for communicating date and condition metadata (e.g., batch, lot, expiry) on ASNs. Under GDP, transport must maintain conditions, document excursions, and preserve traceability of date‑sensitive units through to delivery, with logistics units labeled (e.g., SSCC) and products identified (e.g., GS1 GTIN).

7) Data Integrity—Proving the Proof

Every printed expiry must be traceable to attributed, contemporaneous records. That includes stability datasets with versioned calculations, attributable adjustments to label templates, and audit trails for any change to dates or storage statements. Electronic signatures and system validation (CSV) ensure decisions stand up to inspection and internal review under Data Integrity principles.

8) Sampling, Methods, and Laboratory Controls

Good expiry decisions rely on good measurements. Sampling plans and pull schedules are authored and version‑controlled; methods are validated or verified; instruments remain in calibration status; and calculations are independently checked in LIMS, with scientific reasoning recorded in the ELN where required. Where packaging‑integrity or label‑legibility attributes affect expiry reliability, include those tests explicitly in the stability program.

9) Facilities, Storage Equipment & Excursion Control

Storage environments (cold rooms, freezers, warehouses) must be qualified and monitored, with mapped temperature profiles, calibrated sensors (Asset Calibration Status), and alarm responses that prevent unassessed release. Excursions are documented, impact‑assessed, and linked to affected lots to preserve the validity of the printed date. Where cleaning or maintenance could influence conditions, pre‑use checks are captured in the eBMR and related logs.

10) Packaging, Labeling & Serialized Identity

Expiry must appear correctly and legibly on primary/secondary packaging, along with lot and storage statements. Use governed templates and verified variable data per Label Verification. Where serialization is in scope, ensure that commissioned serials (Serialization) and aggregated logistics units (SSCC) carry consistent date data through scanning and handovers, preventing downstream mismatches.

11) Warehouse Status, FEFO & Distribution Readiness

Dates only protect patients if operations obey them. The WMS should prevent allocation or pick of expired lots, enforce FEFO (or FIFO where justified), and present “days‑to‑expiry” signals at staging to minimize near‑expiry shipments. Inventory under investigation remains in Quarantine or Hold/Release until QA disposition. When released, packing proceeds with verified labels and accurate documents for Pack & Ship.

12) Validation Lifecycle—PV, CPV & Periodic Review

Expiry governance is not a one‑time event. Process Validation establishes the control strategy; ongoing CPV demonstrates that quality remains under control over time and supports the continued suitability of expiry assignments. Periodic review through PQR confirms that complaints, trends, or stability signals do not warrant changes to shelf‑life or storage statements; if they do, implement under MOC.

13) Metrics That Demonstrate Control

• Near‑Expiry Exposure: percentage of shipped units with ≤X days remaining at dispatch.
• FEFO Compliance: picks that follow FEFO vs. exceptions, by site and lane.
• Write‑Off Rate: units scrapped due to expiry, normalized by sales or production volume.
• ASN Date Accuracy: mismatch rate between supplier‑reported and received expiry data on ASNs.
• Excursion Response Time: median time from alarm to QA disposition for affected lots.
• Label Data Defects: ppm of variable‑data errors (date/lot) detected at pack verification.

High‑maturity programs drive these indicators down and keep them there, proving that printed dates and operational behavior align.

14) Common Pitfalls & How to Avoid Them

• Confusing re‑test with expiry. Make explicit which materials may be re‑tested and under what controls; never relabel to extend use without evidence and MOC.
• Ungoverned storage statements. Control wording under Labeling Control; tie changes to stability rationale.
• Manual date entry. Automate variable data population and verify at pack; block pack on mismatch.
• FEFO blind spots. Ensure the WMS sees lot/expiry in every location (including work‑in‑process and off‑site 3PLs) and enforces rules.
• Excursion amnesia. Treat every excursion as a quality event with documented impact and disposition linked to affected lots.
• Unmapped warehouses. Validate storage areas and sensors; without mapping and alarms, dates are not meaningful.

15) What Goes in the Expiry Record

An audit‑ready expiry record identifies the product and lot, storage conditions, assigned expiry or re‑test date, the stability/hold‑time evidence ID supporting the assignment, label template/version used, and the chain of custody for variable‑data printing and verification. It also links any relevant deviations, excursions, or CAPA, and records QA disposition and the effective date/time of status changes under Document Control.

16) How This Fits with V5 by SG Systems Global

V5 Solution Overview. The V5 platform treats shelf‑life as a governed attribute: dates and storage rules are versioned, attributable, and enforced across execution and logistics.

V5 MES. The V5 MES embeds storage requirements and hold‑time controls in the eBMR, prompts stability/hold pulls, and blocks steps when conditions or time limits are exceeded.

V5 QMS. Within the V5 QMS, deviations, excursions, CAPA, and MOC keep expiry assignments and labels in sync with evidence.

V5 WMS. The V5 WMS enforces FEFO, prevents allocation of expired stock, validates expiry on receipt (including ASN cross‑checks), and carries date data through staging and Pack & Ship.

Bottom line: V5 turns expiry dating into an end‑to‑end control—what science sets, operations keep, and records prove.

17) FAQ

Q1. What is the difference between “expiry/use‑by” and “re‑test date”?
An expiry or use‑by date defines the end of permitted use. A re‑test date allows re‑evaluation of material (often an API or raw) to extend use if it still meets specification, under controlled procedures.

Q2. Can we extend shelf‑life without new stability data?
Not defensibly. Extensions require justified evidence (e.g., additional stability time points, supportive trending) and governed implementation through MOC with updated labels and instructions.

Q3. Is “best before” the same as “use‑by”?
No. “Best before” is typically a quality guidance; “use‑by/expiry” is a safety or regulatory limit. Follow sector rules and your approved labeling language.

Q4. How do warehouse rules enforce dates?
By storing lot/expiry as master attributes and applying FEFO allocation and pick logic, with blocks against expired stock and alerts for near‑expiry inventory.

Q5. What if a cold‑chain excursion occurs in transit?
Treat as a quality event: quarantine affected lots, assess impact against stability knowledge, document disposition, and update records before release under GDP.

Q6. How often should expiry assignments be reviewed?
At least during the PQR cycle or when signals (complaints, OOT trends, excursions) suggest risk. Reviews and changes proceed via MOC.

Related Reading
• Science & Evidence: Expiration & Shelf‑Life Control | Hold Time Study | CPV
• Labeling & Records: Labeling Control | Label Verification | Document Control | Data Integrity
• Operations & Logistics: WMS | FEFO | ASN | GDP
• Quality Decisions: Hold/Release | Lot Release | Finished Goods Release