Intro
In pharma and biotech, labels aren’t just for branding — they’re about safety, compliance, and traceability. Regulators demand strict accuracy, and missing even one detail can mean failed audits or worse, risks to patient safety.
This guide breaks down the core requirements for pharmaceutical and biotech labels, from serialization and barcodes to durable substrates and tamper-evident features.
Serialization & Lot Numbers
Serialization ensures every product has a unique identifier.
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Critical for recalls and audits.
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Required for many FDA and global compliance frameworks.
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Lot numbers connect each product back to a specific batch, giving full traceability.
👉 For more background on compliance basics, see our Complete Guide to Product Label Compliance (internal link to pillar post).
Barcodes & GS1 Standards
Barcodes are more than black-and-white stripes — they’re a compliance requirement.
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GS1 standards ensure that barcodes scan correctly across the global supply chain.
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Serialization is often embedded in barcodes to streamline tracking.
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Incorrect formatting can cause major distribution delays.
(GS1 Barcode Standards – outbound link)
Cryogenic & Durable Labels
Biotech products often face extreme conditions:
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Cryogenic storage (as low as -80°C).
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Exposure to chemicals or solvents.
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High-moisture or high-heat environments.
Labels must use special substrates and adhesives that survive these conditions without peeling or smudging.
Tamper-Evident Features
Counterfeiting in pharma is a global problem. Tamper-evident packaging helps protect patients and maintain brand trust.
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Seals that break when opened.
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Labels with VOID patterns or destructible films.
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Layered designs that prevent reuse.
Common Compliance Issues in Pharma & Biotech
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Incorrect or unreadable barcodes.
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Labels that fail in storage conditions.
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Missing or duplicated serial numbers.
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Lack of tamper-evident seals.
Final Thoughts
For pharma and biotech companies, compliance labeling isn’t optional — it’s essential. Labels must perform in the lab, in distribution, and with patients.
👉 At San Diego Label, we partner with biotech and pharma companies to deliver compliant, durable labels that meet the strictest standards — so your products stay safe, traceable, and trusted.