Pharmaceutical packaging and labeling companies have a tremendous amount of responsibility to the entire pharmaceutical industry. If pharmaceutical adhesive labels are left off pharma packages, easily fall off, or have incorrect information, the end patient could misuse their medications, which is clearly a dangerous possibility. That’s why pharma labels manufacturers must follow strict guidelines when it comes to medical packaging.

Manufacturers of pharmaceutical packaging components such as labels must abide by strict processes in their manufacturing processes, for example cGMP or ISO 9001-2015. Continual audits by outside organizations ensure that a manufacturer is in compliance with these requirements.

Here are a few important guidelines for packing pharmaceutical products that, according to the World Health Organization, pharma labels manufacturers have to adhere to:

  1. The quality of the packaging must protect against all adverse external influences that can alter the properties of the product, e.g., moisture, light, oxygen, and temperature variations.
  2. The packaging also must protect against any form of physical damage and biological contamination.
  3. The packaging label must contain the correct information, dosage, and name of the product.
  4. All well-closed containers must protect from loss of substance under normal shipping and handling conditions.
  5. If the container is a tightly-closed container, it must protect from loss of the substance, efflorescence, deliquescence, and evaporation under normal shipping, handling, and storage conditions. It also needs to be airtight after each re-closure if it’s intended to be opened on several occasions.
  6. And if the container is a hermetically-closed container it must be completely impervious to air or any other gas under normal handling, shipping, and storage conditions.

Any error to either the labeling or the packaging can lead to serious public health issues. The World Alliance for Patient Safety reports that annual medication errors cost between $5.8 billion and $27.3 billion worldwide each year. And that’s just the financial costs of medication errors. In the U.S. alone, an estimated 7,000 people die each year due to inappropriately dispensed drugs.

Here are some important medication errors that pharma labels manufacturers should always take care to avoid.

  • Key information such as product name, strength, and dosage is missing or expressed in a confusing manner.
  • Key information is not easily visible.
  • The labels look similar across multiple products from different manufacturers.
  • Confusing or error-prone abbreviations or symbols are used.

When printing adhesive labels for pharmaceutical use, all these guidelines have to be followed. A quality assurance system can often help prevent such issues.


If you want to learn more about custom printed labels, pharmaceutical labels, and pharmaceutical packaging, contact Luminer today for more information.