Pharmaceutical · Serialisation Compliance

Serialisation Compliance for Pharmaceutical Manufacturers

DSCSA full interoperability has been mandatory since November 2023. Revised Schedule M came into force in January 2025. If your serialisation programme is not fully operational, every shipment is a regulatory risk.

Certify Origin DSCSA EU FMD Schedule M CDSCO EPCIS
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Acviss Certify pharmaceutical serialisation compliance
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The Compliance Clock Is Running

Serialisation Mandates Are No Longer Upcoming. They Are In Force.

The regulators set the deadlines. Manufacturers either have a system that meets them or they have a gap. These numbers show how much ground is already in play.

Nov 2023
DSCSA full interoperability enforcement began, affecting every US prescription drug shipment
Source: FDA
Jan 2025
Revised Schedule M serialisation requirements took effect for Indian manufacturers
Source: CDSCO
68%
Of mid-size pharma manufacturers are not fully compliant with at least one serialisation mandate they are subject to
Source: Deloitte Life Sciences Survey
Where Serialisation Programmes Stall

Five Situations Your Team Has Probably Already Encountered

ߓ뼯span> Multiple Mandates, Multiple Deadlines

DSCSA, EU FMD, Schedule M, and CDSCO do not share a common data standard. Your team is managing four compliance programmes that overlap in scope but differ in format. Without a system that outputs all four, you are building and maintaining four separate processes.

ߖ诸Ｏspan> Packaging Line Integration Is the Hardest Part

Serialisation software is one thing. Getting that software to talk to your existing line PLC, vision system, and ERP is another. Most implementation failures happen at integration, not at the compliance layer itself.

ߔ伯span> Artwork Change Cycles Block Fast Deployment

Adding a 2D DataMatrix to your packaging requires artwork approval, regulatory sign-off in some markets, and a print cycle change. For brands with large portfolios, managing this across hundreds of SKUs simultaneously is a coordination challenge.

ߓἯspan> Audit Readiness Is Not the Same as Being Deployed

Some manufacturers have a serialisation system running but cannot produce the audit trail a CDSCO or FDA inspector expects in the format they expect it. Being technically live and being inspection-ready are two different things.

ߌ༯span> Export Markets Add Compliance Complexity

Your primary manufacturing market is India but you export to the US, EU, and the Gulf. Each export destination has different requirements. You need one platform that handles all of them without separate teams managing separate systems.

Regulatory Requirements

Four Mandates With Four Different Technical Specifications

Each market has its own data format, submission mechanism, and inspection standard. Acviss maps to all four so your compliance team configures once and the system handles the rest by destination.

USA DSCSA

Full interoperability has been in force since November 2023. Every prescription drug transaction requires EPCIS 1.2 or 2.0 data exchange between trading partners. The four DSCSA data elements (NDC, serial number, lot number, expiry date) must accompany every transaction. FDA inspectors expect Transaction Information and Transaction History in machine-readable format on demand.

Certify outputs DSCSA four-element data. Origin generates EPCIS transaction events and Transaction History for every supply chain handoff.
EUROPE EU FMD

The Falsified Medicines Directive requires serialisation and tamper verification for all prescription products sold in the EU. Packs must carry a 2D DataMatrix and a tamper-evident device. Serial data must be uploaded to the European Medicines Verification System (EMVS) at the point of manufacture and verified at the point of dispense. EMVS upload spec requires specific data format and connection to the national verification organisation in each EU member state.

Certify generates EMVS-compatible serialisation data. Your EU submissions go directly to the national verification system without manual reformatting.
INDIA Schedule M

Revised Schedule M, effective January 2025, mandates serialisation for all scheduled drugs manufactured in India. CDSCO requires barcode labelling per its published specification and Form 41 data submission for product tracking. The requirements apply to both domestic sales and export. CDSCO inspectors will look for batch-level traceability documentation and barcode compliance at the packaging line level during Good Manufacturing Practice audits.

Certify supports CDSCO barcode specifications. Origin generates Form 41 export data and maintains the batch-level audit trail your inspection team needs.
GLOBAL WHO-GMP

WHO Good Manufacturing Practice guidelines require documented traceability from raw material to finished product for all markets that reference WHO-GMP in their national standards. This covers a large portion of export markets in Asia, Africa, and the Middle East. The documentation chain must cover every manufacturing step, every batch record, and every distribution handoff. WHO-GMP is not a single submission but an ongoing documentation standard across your entire operation.

Origin maintains the WHO-GMP documentation chain across manufacturing, QA release, and distribution. Multi-market compliance rules are configurable per SKU and per destination.
Acviss Products for Serialisation Compliance

Three Products That Cover Your Full Compliance Stack

Certify generates the compliant serial codes at line speed. Origin turns those codes into EPCIS events and audit documentation. Truviss monitors whether your serialised product is being verified correctly once it leaves your facility.

Authentication
Certify

Generates compliant serial codes at line speed for every mandate your product is subject to. One platform, four compliance profiles, zero manual reformatting between markets.

  • GTIN-compliant 2D DataMatrix at line-side printing speeds
  • DSCSA four-element data elements (NDC, serial, lot, expiry) built in
  • EMVS-compatible serialisation data for EU FMD
  • Support for Indian CDSCO barcode specifications
  • Tamper-evident holographic label with digital twin
  • Aggregation from unit to case to pallet for full EPCIS hierarchy
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Track and Trace
Origin

Creates the EPCIS event log that turns serialisation data into compliance documentation. Origin is the audit trail your regulatory affairs team needs to face any inspection.

  • EPCIS 1.2 and 2.0 event generation at each supply chain handoff
  • DSCSA Transaction Information and Transaction History generation
  • FDA-ready audit trail for US market submissions
  • CDSCO Form 41 data export for Indian inspection readiness
  • WHO-GMP documentation chain from raw material to finished product
  • Multi-market compliance rules configurable per SKU and per destination
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Market Surveillance
Truviss

Monitors whether your compliant serialised product is being verified correctly downstream. Serialisation without downstream monitoring is half a compliance programme.

  • Detects when your serialised packs appear on unverified channels
  • Flags authentication failures that suggest diverted or tampered product
  • Online market surveillance for counterfeit listings using your serial format
  • Grey market detection for product verified in the wrong geography
  • Takedown evidence packaging for IP enforcement
  • Compliance intelligence for your legal and regulatory affairs teams
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See How Acviss Supports Pharma Track And Trace

Get a tailored track and trace plan for your Pharma products and channels.

  • ✅ Risk Audit: We map your Pharma product, channel, and customer journey.
  • ✅ Live Demo: See Acviss track and trace workflows on your use case.
  • ✅ Tailored Rollout: Get a practical deployment plan for your products and existing systems.

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Frequently Asked Questions

Questions Your Team Is Probably Already Asking

The fastest path is usually starting with your highest-volume or highest-risk SKUs rather than trying to serialise your entire portfolio at once. Certify can be deployed at line level in 8 to 12 weeks for a single packaging line. We have handled urgent deployments for clients under regulatory scrutiny and can prioritise accordingly.
Certify supports full EPCIS aggregation hierarchy. Each unit gets a SGTIN, cases get aggregation events, and pallets get a SSCC. The aggregation data feeds directly into Origin for DSCSA Transaction Information generation. Your logistics team sees the full hierarchy in the dashboard without manual data entry.
Yes. Certify manages multiple compliance profiles on one platform. The same serialisation engine outputs DSCSA-formatted data for your US shipments and EMVS-formatted data for your EU shipments. Your compliance team configures the market-specific rules once and the system applies them automatically by destination.
Certify handles interrupted runs with a gap reconciliation workflow. The system identifies which serial numbers were printed, which were confirmed as applied, and which are unaccounted for. Unaccounted serials are decommissioned in the system. The batch audit trail records the interruption event for regulatory transparency.
We have a structured SKU migration programme. Your regulatory affairs team prioritises SKUs by compliance urgency and print cycle timing. We provide artwork specifications for each SKU so your packaging designers can make the minimum required change. For SKUs with long print cycles, we offer an interim stick-on label option to meet compliance deadlines without waiting for a full print run.
Both models work with Certify. Some contract manufacturers operate their own Certify instance and share data with their clients. Others use a client-supplied system and Certify handles the line integration. We have documentation for both approaches and can advise based on your client mix and contract terms.

Compliance Deadlines Do Not Move. Your Serialisation Programme Should.

Book a call and we will map your specific mandates, SKU portfolio, and packaging lines to a deployment timeline that gets you operational without disrupting production.

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