Pharmaceutical label printing involves several factors that need to be considered. These include traceability and quality control. Then, there’s cost. Government regulations also have to be considered. There are many different types of label materials available, and choosing one is an important decision. Expert label printers will consider the pros and cons of each material before making a recommendation. They will also provide reliable testing data to back up their recommendations.
Traceability
With the growing need for traceability, pharmaceutical manufacturers are turning to labeling services. Traceability helps them meet regulatory requirements and strengthen their supply chains. It also allows them to track and trace their products, ensuring patient safety. It is important for companies to partner with a labeling service that has advanced technology, equipment, and supplies. These companies can provide customized solutions that fit the unique needs of each client. In addition, traceability solutions improve label printing speed and brand integrity.
Traceability printing provides a unique identifier for each product. This identifier allows users to follow the products through the supply chain, from the laboratory to the retail store. Creative Labels offers many options for traceability, including tamperproof films, destructible films, and holographic papers. The company also offers special security laminates.
Pharmaceutical Companies
Pharmaceutical companies must label their medications both during preparation and transfer to the retail market. These labels must include crucial information like the medication name, dosage, and diluent, and the expiration date. They must also comply with FDA regulations regarding traceability. Because of the high-risk of counterfeiting, pharmaceutical manufacturers are increasingly turning to barcodes, randomized tracking numbers, and hidden images on pharmaceutical labels. These features make counterfeiting more difficult. They also prevent gray-market trade.
Traceability is one of the most pressing issues for the pharmaceutical industry. DSCSA requires that pharmaceutical manufacturers produce serialized labels that meet the new guidelines. The deadlines for compliance are coming up in 2017 and 2018, and it is imperative for companies to invest in track and trace printing solutions. The printing component of this process is often overlooked, but it can make or break the effectiveness of the program.
Pharmaceutical manufacturers can meet stringent traceability standards by implementing reliable printing equipment and establishing a reliable marking workflow. They must also maintain accurate lot records and be able to access that data easily. Modern technology makes this process easier and faster, and it helps pharmaceutical manufacturers find and trace products quickly and easily. It also enables them to perform recalls and verify counterfeit products.
Government Regulations
Whether you’re looking to print a label for a prescription drug, cosmetic, or medical device, pharmaceutical labels must adhere to stringent guidelines. These guidelines are lengthy and vary from drug to drug. Federal regulations require labeling of drugs, products, and packaging to include the active ingredients, net product quantity, and directions for use.
The proposal would place an administrative burden on the industry and detract from efforts to improve patient safety. The proposal also makes an artificial distinction between OTC and prescription drug products, placing the burden on manufacturers, repackers, and private label distributors of OTC drug products. Moreover, the proposal requires drug manufacturers to certify all label printing, which is an unnecessary and time-consuming process.
National Association of Boards of Pharmacy
A number of comments focused on small drug containers. Some manufacturers and a trade association argued that small containers should be exempted from the regulations. Comments specifically mentioned 5 mL vials, prefilled syringes, blister packs, and small ophthalmic containers. They also suggested that vaccine unit-of-use containers be exempted.
The National Association of Boards of Pharmacy (NABP) has published recommendations that supplement the federal requirements for pharmaceutical label printing. The NABP recommends that all pharmaceutical labels bear the name of the drug product dispensed, the manufacturer or distributor, the date beyond-use of the drug product, the quantity dispensed, the number of refills, and the pharmacist’s name or initials.
Whether or not the label on a prescription drug contains all of the information needed to protect consumers, it is required to bear a clear warning. If the label fails to contain the information required by the patient, then it is considered misbranded.
Cost
Pharmaceutical labels must be accurate. As a result, quality control and inspection is critical. In addition to checking every single label, these labels may also require special cuts and materials that can stand up to cleaning and handling. One example is a tactile mark, which is a raised area on a pharmaceutical label that can be felt by the tips of your fingers. Such a feature is especially useful in pharmaceutical products and can help the blind identify potential dangers. However, this feature also adds to the overall cost.
Prescription drugs undergo a long process and the labels on these products are critical. These labels include dosage information and important identifiers. For example, they tell pharmacists and pharmacy assistants who a prescription is for. It is important for pharmaceutical companies to ensure that these labels are accurate and detailed. Pharmaceutical labels must also be waterproof and adhere securely to bottles.
Pharmaceutical Labels Printing Quality
In addition to the print quality of the pharmaceutical labels, these labels must be compliant with cGMP regulations. Consequently, manufacturers are required to carefully inspect their labels before they are sent to the marketplace. This inspection is done to ensure that the labeling matches what is specified in production records. The recent ruling by the FDA does not diminish the necessity of label inspection. The FDA still requires a 100% visual inspection of all printed information on every label.
Pharmaceutical labels are required to have unique and traceable data. This information is not limited to an image, but is related to a variable, unique code. This is an attempt by governments to prevent fraud in the pharmaceutical industry.
Options
Choosing the right label printing technology is important for pharmaceutical companies. This is because deviations in quality can affect human and animal health. Pharma labels must meet strict standards for safety and quality. Fortunately, there are many different options for pharmaceutical label printing. Some companies offer full packaging solutions and other features that help them stay within FDA regulations.
While most pharmaceutical companies will use conventional label printing methods, some prefer going digital. This process produces full-color labels in a more cost-effective manner. Digital printing technology has been around for a few decades, but narrow-web digital presses have only recently become available. A good label printing supplier should understand the FDA’s strict requirements for labeling and adhere to them.
Pharmaceutical Label Production
Pharmacies require clear, accurate pharmaceutical labels. This makes it important to have a reliable in-house label printer that can handle all aspects of pharmaceutical label production. NeuraLabel printers are ideal for this application, as they provide fast turnaround and flexibility. They also ensure quick compliance with FDA-mandated labeling changes. Another excellent choice for pharmaceutical label printing is the Sirius label printer.
Pharmaceutical label printing can be costly. You can outsource your label printing requirements, but you have to consider several factors, including the time it takes to receive your labels. If you are outsourcing, you may have to wait several weeks for your labels, which limits the amount of design changes you can make. Moreover, you must take into consideration the loss of production. Loss of production from a single unhappy customer can cost you a great deal.
Pharmaceutical label printing companies should understand your company’s unique requirements and be willing to work with you to meet them. An experienced company can advise you on the best materials and solve any problems that may arise. Proper communication is essential in the process, and you should be able to reach your labeling company at any time with any questions or concerns.
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