Labelling is an essential part of packaging for the sale of drugs and medical devices. It provides a product ID, instructions for use and safety information – all of which must remain intact and legible throughout the product’s lifecycle.
Specifically for medical devices, ISO 13485 defines labeling as the “label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device.” While that standard does not specifically define labelling for pharmaceuticals and other life science products, similar concepts apply. The labelling must also address risk management – hazardous materials and proper usage details, which are crucial to the safety of the consumer. Every individual product will have its own specific uses and instructions, so every label may be unique. Missing labels or illegible print can result in misbranded products, which may lead to patient safety risks, product recalls, and the consequent damage to your brand’s reputation.
Executing a well-planned label material and print qualification will ensure that your product’s labelling remains intact during distribution, storage and usage and will mitigate risks created by faulty labelling.
Label Lifecycle
Outer packaging print and labels must survive the supply chain and product lifecycle intact. To ensure compliance, labelling must be designed to account for variable such as temperature changes, weather, sunlight, handling abuse and transportation hazards. Labelling must hold up against these factors to ensure it does not degrade or become unreadable before the product’s expiration date.
To ensure label integrity, packages, cases, shippers and pallets with thermal transfer labels must undergo rigorous testing. This also helps ensure that the labels remain compliant and legible throughout the package’s lifecycle.
Label design and the means of decoration must be selected to suit the specific needs of the product and its packaging, distribution environment and end user; thermal transfer, foil-printed, ink-printed and label-abraded labels aren’t one-size-fits-all solutions. This need for customization can make qualification challenging, as the label needs to hold up for the life of the product.
Testing for Label Durability
A qualification must evaluate the effects of distribution and handling conditions on label adhesion and print legibility, including temperature exposure, shock and vibration.
Environmental simulations should be representative of expected temperature and humidity exposure, including extremes. Freeze/thaw processes representative of conditions found during drug and medical device manufacturing and distribution should be included in the testing simulation if the packaging and the product are to remain viable at the end of the distribution.
Exposure to simulated distribution conditions will confirm that label quality is not affected in transit. Surfaces of materials such as corrugate shippers are abrasive and can damage labels packed in shipping containers that are exposed to vibrations. Exposure to shock and vibration can also cause label tearing, wrinkling, and other damage.
Accelerated and real-time aging studies simulate storage throughout the labelled shelf life of the product and will identify if degradation of the label material, adhesive or print will occur over the shelf life of the packaged product. The possibility of label adhesive or ink migration over time from a label applied to a primary drug container should be evaluated to reveal potential risks.
An understanding of the process used for manufacturing and distribution of a drug or medical device will determine if the packaging’s exterior shipping surface may be exposed to solvents or other chemicals. Smeared or missing print, destruction of the label surface or removal of the label adhesive could occur. Isopropyl Alcohol, other antiseptics and surface disinfectants can come in contact with the labelling if the package is wiped down or opened by a healthcare practitioner handling an antiseptic as part of dispensing the product. A test simulating the dispensing or processing conditions will confirm whether the printed labels are chemical resistant or not. Additional product contact testing with the printed labels will also provide label resistance due to manufacturing leakage or residue, in addition to handling issues.
Requirements & Considerations of Life Science Packaging Labels
Despite the similarities between drug and medical device labeling requirements, there are some differences, especially within the recent serialization and UDI regulations. Most of these labelling requirements are specified in the Code of Federal Regulations (CFR), but other labelling requirements come from industry standards, individual country requirements and specific industry agreements within the supply chains of the pharmaceutical and medical device industries.
Beyond the CFR labelling guidance provided by the FDA, the pharmaceutical industry follows GS1 standards and additional guidance provided by the Healthcare Distribution Alliance (HDA). The medical device industry uses GS1 standards and also incorporates standards set forth by the International Organization for Standardization (ISO).
Some requirements – such as the inclusion of a lot code, expiration date, product name, product code, NDC number and barcode – are common across all industries and markets. Additionally, there can be subtle differences in requirements for print format, location and the required content of the text on the label. Requirements may also vary as they pertain to inclusion of manufacture date or expiration date formatting.
For example, the pharmaceutical industry in the U.S. primarily adheres to the MMM YYYY alphanumeric format, e.g. DEC 2025, for its expiration dates. U.S. medical device manufacturers tend to apply ISO’s standard numeric MM YYYY format, e.g. 12 2025, for expiration dates.
Bar code requirements and the creation of the content linked to them present a unique set of challenges. Pharmaceutical manufacturers must apply the FDA’s Drug Supply Chain Security
Act (DSCSA) rules, while medical device manufacturers must adhere to the FDA’s Unique Device Identification (UDI) system. As a note, naming conventions for barcode content differ significantly between pharmaceutical products & medical devices.
Pharmaceutical brands include Global Trade Identification Number (GTIN), Serial Shipping Container Code (SSCC) and serial number in their barcodes, where bar codes on medical device labels must include UDI-DI and UDI-PI attributes along with the serial number for the product. Pharma brands must convert their NDC number into a GTIN when applying a bar code, while medical device brands must convert their UPC code into a GTIN.
For shipping labels, manufacturers of pharmaceutical products typically apply Healthcare Distribution Alliance (HDA) rules, while most medical device manufacturers adhere to standards issued by ISO. There are also Labeler Codes that identify the organization that prints and applies the labels to the product. The pharmaceutical industry generally relies on GS1 for their Labeller Codes and registration, while medical device manufacturers obtain their Labeller Codes and registration from the Health Industry Business Communications Council (HIBCC).
For packaging professionals in the life science industries, the mix of regulations, industry standards, and labeling best practices can be confusing, hence important for individuals working in those industries to understand the complex interaction of these regulations and standards to complete a successful label qualification to ensure the proper regulatory compliance which is applicable to those industries’ governing body standards. There is no consolidated resource or central repository for these rules, so a packaging team’s best asset is a labeling expert with experience navigating the complex landscape of pharmaceutical or medical device labeling standards and regulations.
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