Intro
In pharma and biotech labeling, accuracy is more than a requirement — it’s a matter of safety and compliance. Regulators demand strict precision, and missing even one detail can lead to failed audits or, worse, risks to patient safety.
In this guide, we’ll explain how labeling works, covering serialization, barcodes, substrates, and tamper-evident design — so your labels meet every regulatory standard.
Serialization & Lot Numbers
Serialization ensures that each product has a unique identifier. As a result, every package can be tracked through manufacturing, distribution, and patient use.
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Why it matters: It’s critical for recalls and audits.
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Regulatory role: Required for FDA and many international compliance systems.
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Lot numbers: Connect products to their specific batch for full traceability.
Barcodes & GS1 Standards
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Barcodes do more than identify a product — they’re essential for traceability and automation. Pharma and biotech labeling must follow GS1 barcode standards to ensure codes scan correctly across the global supply chain.
In addition, serialization data is often embedded directly in barcodes to streamline tracking and avoid duplication. However, incorrect formatting or low-quality printing can delay entire shipments.
Learn more from the GS1 Barcode Standards.
Cryogenic and Durable Labels for Pharma and Biotech
Pharma and biotech labeling often faces temperature and chemical extremes. For example:
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Cryogenic storage as low as –80°C
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Contact with solvents, alcohols, or cleaning agents
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Moisture, heat, and freezer cycling
Therefore, labels must use cryogenic substrates, durable films, and specialty adhesives that resist peeling and fading. When done right, these labels stay legible through years of handling and testing.
Tamper-Evident Labeling in Pharma and Biotech
Counterfeiting is a growing global threat. Tamper-evident features help protect patient safety and product authenticity.
For instance:
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Seals that break upon opening
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VOID-pattern adhesives or destructible materials
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Layered films that prevent reuse
As a result, tamper-evident pharma and biotech labeling helps companies maintain trust, protect consumers, and comply with regulatory mandates.
Common Compliance Issues in Pharma and Biotech Labeling
Even large organizations can make labeling errors. For example:
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Incorrect or unreadable barcodes
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Labels that fail under temperature stress
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Missing or duplicated serial numbers
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Absence of tamper-evident seals
Because of this, many companies turn to specialized label converters like San Diego Label to ensure every label meets performance and regulatory expectations.
Final Thoughts
In pharma and biotech labeling, compliance is not optional — it’s the foundation of trust and safety. Durable materials, accurate data, and secure features keep your products protected from production to patient use.
At San Diego Label, we partner with pharmaceutical and biotech companies to design, print, and verify compliant labels that meet the strictest standards.
👉 Contact San Diego Label today to discuss your labeling needs.