Pharmaceutical Track & Trace Solutions
Ship only the right molecule, lot and serial number—every vial, strip and carton—while regulators and customers watch.
One Mis-Serial Can Stop a Launch
- Market recall worth crores
- Import ban into EU/US
- Show-cause notice from CDSCO
- Brand damage that lives on Google forever
- If your “serialization” is still a spreadsheet plus vision camera, you’re one scan away from disaster.
Our Pharma Toolkit
- Thermal or RFID labels that survive –20 °C cold chain, +60 °C trucks, gamma sterilisation.
- High-speed printers (300 packs/min) with built-in vision verification.
- Level-3 / Level-4 software that generates unique GS1 serials, uploads to EU-Hub, US-DLMS, India-IPC.
- Tamper-evident labels with void pattern and covert DNA ink for anti-counterfeit.
Use-Cases on Your Line
- Blister Serialization – Camera verifies print grade ≥ C; rejects auto-diverted, no line stop.
- Aggregation – Bundle, case, pallet scanned in 3 sec; parent-child file ready for wholesaler.
- Sample Testing – QA pulls random serials; system freezes numbers, prevents accidental export.
- Returns & Recalls – Upload affected serials; wholesaler app flags in real time, scope down to 200 cartons instead of 20 000.
Benefits You Can Bank
- 99.9 % serialization accuracy—no failed uploads, no market block.
- 30 % faster change-over—format files stored per SKU, auto-called.
- 100 % tamper evidence—covert ink + void label stop grey-market diversion.
- Audit ready—generate EU FMD or US DQSA report in two clicks.
- Revenue protection—launch on schedule, avoid penalty clauses.
Built for Regulators You Fear Most
- Supports GS1 GTIN, SSCC, expiry, batch, serial, NHRN (India).
- Level-4 archive keeps 15-year record, 21 CFR Part 11 compliant.
- Blockchain-ready hash for brands that need “seed-to-patient” proof.
- Software validated per GAMP5 with full IQ/OQ documentation pack.
Proof in the Field
Top Indian CMO
Serialised 400 SKUs for EU market; passed notified body audit in 3 days.
Ophthalmic plant
Reduced recall scope 95 %—traced defective batch to 1 200 vials, not 120 000.
Export house
Saved ₹8 Cr launch delay by catching duplicate serials before ship-off.
Why Hi-Tech
- 25 years only barcode & RFID. GS1 India solution partner.
- In-house label plant prints 200 000 tamper-evident labels overnight.
- Validated software, validated hardware, one contract, one throat to choke.
- Support engineer on WhatsApp <30 mins, 365 days.
Lets Get in Touch!
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Call us
+91-9311596350
Email us
info@hitechbarcodesolutions.com