Challenges of Pharmaceutical Label Printing Services

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Pharmaceutics labels need to provide a lot of information. To get started, here are some tips to help you decide what to put on your labels. You should know how much information is needed, as well as what challenges you might face. And, of course, you should always consider the cost. Read on to learn how to make the most of pharmaceutical label printing. Listed below are some common challenges, and how to overcome them. And don’t forget to check out our other articles to learn more about label printing.

Information Needed on Pharmaceutical Labels

Pharmaceutics products, including prescription drugs, must have accurate information on their packaging, labels and other materials. These rules are outlined in Title 21 of the Code of Federal Regulations. If manufacturers fail to follow these guidelines, the FDA has the power to revoke a drug’s marketing approval and misbrand it. Information needed on pharmaceutical labels includes the primary labeling of the drug, the packaging insert and a statement of identity.

A patient guide should be included in the label if the product is approved by the FDA. Whether this information is required will depend on the regulations. In general, the information on drug labels must be easily understood and legible. For example, a manufacturer must include a limitation statement if a drug is sold under a brand name. Further, the label must include information on tamper protection. Lastly, the product should include a summary of all important information.

Basic Elements of Label

The basic elements of the label include a description of the drug, ingredients and a warning statement. In addition to this, the pharmacology and toxicology sections should include information about the action and effect of the medicine. These sections should also alert patients to the potential side effects and long-term consequences of taking the medicine. Additional elements on a medicine label include a clinical study summary, storage and handling instructions and patient counseling.

Besides the name of the drug, the label should include the concentration of the drug. It should also state the date of preparation and the preparer’s initials. It may also contain the patient’s name. Another standard for pharmaceutics packaging is ISO 26825:2008 for syringes and other delivery systems. It also covers the use of colour on the label. Further, it specifies that a label must be legible if it must meet certain requirements.


Despite the advantages of modern digital printing technology, there are a number of challenges that pharma companies face. For example, global companies face stringent government mandates and must maintain multiple label templates for various countries. The industry is also prone to mislabeling. But what are the top challenges of pharmaceutical label printing? Here are a few of them.

One of the biggest challenges is localization. Localization involves creating labels that have the characteristics of a particular country or region. This is especially important for international organizations looking to expand into new markets. Products from food to medical devices are often shipped to many different countries. These labels must comply with the country-specific labeling regulations and language requirements. If these factors aren’t addressed correctly, consumers could become distrustful of a brand.

New Technologies

New regulations are requiring pharmaceutical manufacturers to adopt a more modern approach to labeling. Ultimately, they are trying to lower costs while maintaining high-quality standards. Increasing demand for pharmaceutical products is also driving manufacturers to find more efficient ways to manufacture them. This includes modern digital printing equipment. This type of printing equipment can save a lot of money while retaining high-quality standards. However, these new technologies are not without challenges.

The quality of printed packaging plays a critical role in any industry. Proper label printing will ensure that it is legible and accurate. Additionally, pharmaceutical packaging will need to adhere to several governmental regulations. Inaccurate print quality can cause massive recalls and result in lost inventory. Further, the quality of pharmaceutical packaging can negatively impact the safety of patients. It’s important that all print quality requirements are met. If there is a printing error, it can affect their health or even their lives.


Pharmaceutical labels are important documentation for inventory operations, which requires that they contain accurate and timely information. Label printing software can provide centralized printing information, which reduces costs, complexity and the risk of error. Pharma companies are increasingly integrating enterprise resource planning (ERP) systems with label printing software to streamline the process. This can help pharmaceutical companies ensure compliance and avoid costly mistakes. Here are some of the benefits of using a pharmaceutical label printing software solution.

Pharma companies know that their labels must meet strict FDA regulations. These documents need to be crystal clear and legible, with ultra-specific formatting. These companies should be careful to hire a label printing company with pharmaceutical expertise and knowledge. Pharma companies should also consider pricing when selecting a label printer. This ensures quality and consistency and avoids the risk of a costly recall.

Type of Label Printing

Modern label management systems also include features to simplify the process of label management. For example, a centralized digital label catalogue eliminates the need for manual catalogs. These systems also allow for user-defined, configurable approval workflows, electronic signatures, and role-based access. In addition, these solutions also enable fast processing of change requests. They can help you improve label compliance with regulatory standards. Listed below are some of the benefits of using pharmaceutical label printing software.


The cost of pharmaceutical label printing may seem high, but the benefits can far outweigh the cost. Moreover, they will ensure compliance with government guidelines. The best way to save money on pharmaceutical label printing is to make sure that your pharmaceutical label printing equipment meets all your requirements. Contact Pack Leader USA for free labeling equipment consultation!

Regardless of the labeling process you use, quality is always a top priority. Pharmaceutical labels must be easy to read and comprehend. There are a variety of different regulations and laws that govern pharmaceutical label printing. Failure to adhere to these regulations can be costly, with the cost of reprinting or replacing a label ranging from a few dollars to hundreds of thousands.

Physical Labels Requires

Creating physical labels requires significant time and money. Pharma companies spend millions of dollars on artwork and printing services companies, then spend time and effort figuring out logistics for distributing these updated labels. Because of these costs, pharmaceutical companies may choose electronic labels instead. The electronic versions are available anywhere and can include patient information leaflets and package inserts in different languages. Pharmaceutical companies can also use machine-readable barcodes and QR codes on product cartons.

In addition to the cost of pharmaceutical label printing, the quality of these labels is also a key factor. Using vision inspection systems and bar code scanning can ensure high-quality pharmaceutical labels. Even a missing period of 1.5 mils can be dangerous. In fact, a missing period of a single millimeter could result in the death of a patient.


Modern healthcare supply chains make traceability of pharmaceutical labels and packaging essential to protect patient safety.  The traceability of pharmaceutical products is important for both the company and the consumer. These laws also mandate that pharmaceutical manufacturers follow important labeling regulations, such as the cGMP (currently known as Good Manufacturing Practices).

New Regulations Requiring

The FDA has recently approved new regulations requiring pharmaceutical manufacturers to include a unique identifier on all of their products. In addition, traceability allows companies to track their products as they move through the supply chain and into stores. Many companies offer traceability solutions. For example, Creative Labels offers destructible, tamper-proof, and holographic films to ensure the quality of the product.

Another important feature of traceability is order reporting. Since pharmaceutical labels serve as the unique identifiers of medical devices, they need to have accurate information on them. Label printers with ECM suites can automate this process, sending reports to the proper parties, and creating digital copies for backups and quick dissemination. This ensures better quality control and reduces errors. It also allows companies to track their orders more efficiently, which is a significant benefit for pharmaceutical manufacturers.

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