Labeling, GS1 & Serialization in Regulated Supply Chains — From Intake Labels to UDI & DSCSA

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

Updated November 2025 • GS1-128 case & intake labels, GTIN, SSCC, Application Identifiers, EPCIS, label verification, cartonization, ASN, UDI, DSCSA, serialisation, traceability, code quality • Food & Beverage, Sausage & Meat, Bakery, Produce, Dietary Supplements, Pharma, Medical Devices, Cosmetics, Chemicals

Labels and codes are the only part of your system the outside world ever sees. They carry your brand, legal declarations, allergens, instructions, dates, lots, serials and GS1 identifiers. In a recall, foreign-material incident or device field action, they are often your only handle on product in the market.

On a good day, your label architecture ties every code on every unit, case and pallet back to specific batches, lots, genealogy and decisions. On a bad day, labels are Word templates, codes are retyped by hand, printers are “calibrated” by eye and traceability collapses the moment product leaves the dock.

“If you can’t look at a unit, case or pallet label and, in one step, see its product, lot, serial, route, batch and genealogy, you don’t have traceability. You have ink and hope.”

1) GS1 basics — GTIN, GS1-128, AIs and SSCC

At the heart of standardised labelling and serialization are GS1 identifiers and barcodes:

• GTIN — Global Trade Item Number. GTIN uniquely identifies trade items at unit, inner, case or pallet level, forming the basis of product identity in GS1 systems.
• GS1-128 case labels. GS1-128 case labels encode multiple data elements (GTIN, lot, dates, weights, serials) using Application Identifiers (AIs), in a 1D barcode format widely used on cases and pallets.
• SSCC — Serial Shipping Container Code. The SSCC uniquely identifies logistics units (pallets, totes, containers) for shipping and warehouse control.
• Application Identifiers (AIs). AIs define the meaning of data in a GS1-128 barcode: e.g., 01 for GTIN, 10 for lot/batch, 17 for expiry, 37 for count, 21 for serial, etc.

Getting GTIN, GS1-128 and SSCC right is the foundation for readable labels, interoperable traceability and retailer compliance. V5 uses these IDs when printing case/pallet labels and when capturing scan events at intake, internal movements and shipping.

2) Raw-material intake & internal labels

Your glossary already breaks down intake labelling in the meat context, but the same patterns apply across sectors:

• GS1-128 raw-material intake labeling. GS1-128 raw-material intake labeling assigns each inbound pallet, tote or combo an intake label encoding supplier, product, lot, weight and dates.
• Intake label capture. GS1-128 intake label capture is the process of scanning and recording these labels at goods receipt, tying them to internal lot IDs in WMS.
• Internal movement scanning. GS1-128 internal movement scanning keeps traceability intact as raw materials move between coolers, processing rooms, buffers and lines.
• Lot transfer scanning & re-labelling. Lot transfer scanning and post-smokepath GS1-128 re-labeling describe how to keep traceability intact when lots are repacked, combined or split.

At this layer, labels are the glue between physical materials and WMS/MES data. If intake labels are sloppy, your traceability and mass balance will be too.

3) Label control, artwork & claims — governance before printing

Before you worry about barcodes, you need to control what the label says and how it looks. Your glossaries capture this under:

• Labeling control, artwork & claims changes. Labelling control covers governance for artwork, ingredient lists, nutrition panels, allergens, claims, legal copy and codes.
• Quality by Design & regulatory alignment. Entries like QbD, 21 CFR 101 (food labelling) and cosmetic claims substantiation show how labels must match formulation and evidence.

This governance usually lives in QMS and regulatory functions, but the decisions must flow into the label templates used by V5 and your printers. Change control is critical: label changes must go through the same rigor as recipe or equipment changes, with impact assessment on inventory, artwork, allergens, gradings and retailer codes of practice.

4) Label verification & code quality

Printing labels is one thing; proving they are correct and readable is another. Your glossary includes:

• Label verification / barcode & UDI checks. Label verification is about checking both content and print quality: correct GTIN, lot, dates, serials; correct data structure for GS1; adequate contrast and quiet zones; no truncation; human-readable matching machine-readable.
• Code verification & retailer requirements. Retailer programmes (e.g. Walmart SQEP, Costco) often include minimum quality grades for barcodes and expectations for scannability at distribution centres and stores.

In V5, in-line or off-line scanners can be used to verify labels at print time or at key checkpoints (end of line, palletisation, shipping). Failures should block progression, trigger reprints and open deviations when thresholds are exceeded.

5) Cartonization, right-size packing & aggregation

Once you have unit labels, you need to aggregate them into cases and pallets. Your glossary references this under:

• Cartonization & right-size packing. Cartonization deals with deciding how units go into cases and how cases are labelled and built to minimise waste and damage.
• Serialization & aggregation. Serialization / unique unit identification and the SSCC entries describe how individual units, cases and pallets are given relationships: “these 12 units are inside this case; these 45 cases are on this pallet.”

In practice, that means:

• Each case label links to the GTIN and lot of contents and, in serialised environments, to the serial numbers of units within it.
• Each pallet (SSCC) label points to the cases it holds and possibly to the customer or route.
• V5 WMS/MES maintain aggregation relationships so EPCIS events or traceability reports can show where each unit ended up.

6) Serialization, DSCSA & UDI

For some industries, label and code control goes beyond GTIN/lot to true unit-level serialization:

• Serialization / unique unit identification. Serialization assigns unique IDs to individual packs or devices, often encoded using GS1 or other schemes.
• Drug Supply Chain Security Act (DSCSA). DSCSA requires serialisation and traceability for prescription drugs in the US, including exchange of EPCIS events between trading partners.
• Unique Device Identification (UDI). UDI is a system for identifying medical devices via device identifiers (DI) and production identifiers (PI) encoded in barcodes or RFID, with related submissions to databases like GUDID and AusUDID.

In these contexts, V5 does not try to be a full serialisation server, but it must:

• Consume serials from a serialisation engine or management system and print them correctly.
• Capture scan events at packaging, aggregation and shipping so pallet and case movements can be tied to serials.
• Feed EPCIS or other event streams to serialisation repositories and downstream partners.

That’s where your EPCIS traceability standard entry comes into play.

7) EPCIS events, ASN & shipping documentation

When product leaves the site, labels and codes become the primary interface with customers and regulators. Your glossaries highlight:

• EPCIS traceability standard. EPCIS describes events like commissioning, packing, shipping, receiving and transformation applied to GS1 identifiers. It’s a backbone for DSCSA, some food traceability programmes and device tracking.
• Advance Shipping Notices (ASN). ASN messages list what’s on a shipment—SSCCs, GTINs, quantities, lots, serials—and when it is expected to arrive.
• Shipping manifest & BOL. Shipping manifest and bill of lading (BOL) provide legal and operational handover documentation to carriers.

In V5 WMS, this typically looks like:

• Assigning pallets (SSCCs) and cases to shipments and loads.
• Generating ASNs and shipping manifests that reflect the real, scanned content of trucks.
• Feeding EPCIS events (shipping) into traceability repositories, DSCSA / UDI / retailer networks.

8) How V5 Traceability manages labels, GS1 & serialization

V5 Traceability treats labelling and coding as core execution and traceability functions:

• Central label templates. V5 maintains label templates under document/change control, pulling live data from MES/WMS (GTIN, lot, dates, weights, serials, SSCCs) and pushing them to printers.
• GS1-aware printing. AIs, GTIN formatting, check digits and serial ranges are handled by V5 integrations and label engines, not by operators editing free text.
• Scan-based verification. V5 uses scanners at critical points to validate labels and codes before progression (start of run, in-line checks, end of line, pallet build, shipping).
• Aggregation & EPCIS. V5 WMS maintains aggregation relationships (unit→case→pallet→shipment) and can emit EPCIS or equivalent events for external traceability systems.
• Integration to serialisation servers. Through V5 Connect, V5 can request, apply and report on serials provided by dedicated serialisation systems, while still handling on-floor printing and scanning.

That means your labels and codes become reliable entries into your genealogy and traceability system, rather than a weak link between digital records and physical product.

FAQ — Labeling, GS1 & Serialization in Regulated Supply Chains

Q1. Do we need GS1-128 and SSCC if we only ship domestically?
Strictly speaking, no—but many retailers, 3PLs and distributors expect GS1-compliant labelling regardless of geography. Using GTIN, GS1-128 and SSCC from the start simplifies EDI, ASNs, traceability and future expansion, and avoids “home-grown” code schemes that don’t scale.

Q2. What’s the difference between GTIN, lot codes and serial numbers?
GTIN identifies the product type (e.g., “500 ml shampoo X”). Lot codes identify a production lot or batch (e.g., all units made on a given line/run). Serial numbers identify individual units uniquely. Many food applications use GTIN + lot; pharma and some devices require GTIN + serial (and often lot/expiry) on each unit.

Q3. How does EPCIS relate to internal traceability?
Internal traceability relies on your MES/WMS genealogy and batch-to-bin models. EPCIS is a standard for sharing traceability events (commissioning, shipping, receiving, aggregating, transforming) between trading partners. V5 supplies the internal data EPCIS events need; a serialisation or traceability server often handles external exchange.

Q4. Do we need a full-blown serialisation system for food and cosmetics?
Usually not. Most food and cosmetics are satisfied with GTIN + lot + date-level traceability, plus GS1-128 on cases and pallets. Serialization is typically mandated for prescription drugs and many devices. However, some high-value or high-risk products (e.g., infant formula, certain cosmetics) may use serialisation voluntarily to fight diversion or counterfeiting.

Q5. How do we stop operators changing label layouts or codes on the fly?
By controlling label templates and data sources at the system level. Templates should be managed under document and change control; production operators should select only approved templates and jobs, not edit layout or data fields. V5 enforces this by centralising templates and pulling variable data from MES/WMS, not from operator free-text entry.

Q6. Where should we start if labels are currently built in Word and codes are typed by hand?
Start with one product family and one line. Define standardised label templates, implement GS1-128 case labels and simple SSCC pallet labels, and connect them to V5 WMS for lot and quantity data. Add scan-based verification at key points. Once that works, extend to more products and begin planning for ASNs and EPCIS if your customers or regulators require them.

Related Reading (Glossary)
• GS1 IDs & Codes: GTIN | GS1-128 Case Label | SSCC | Application Identifiers
• Intake & Internal Labels: GS1-128 Raw-Material Intake Labeling | GS1-128 Intake Label Capture | GS1-128 Internal Movement Scanning | GS1-128 Lot Transfer Scanning | Post-SmokePath GS1-128 Re-Labeling
• Label Control & Serialisation: Label Verification / Barcode & UDI Checks | Labeling Control, Artwork & Claims | Serialization / Unique Unit Identification | DSCSA | UDI | EPCIS Traceability Standard
• Logistics & EDI: Advance Shipping Notice (ASN) | Shipping Manifest | Bill of Lading (BOL)
• V5 Platform: V5 Solution Overview | V5 WMS | V5 MES | V5 QMS | V5 Connect API