Pharmaceutical label Printing are highly regulated and must meet stringent quality requirements to comply with government regulations. They must also deliver critical information to those reading them. While eye-catching graphics and eye-catching colors are not always required, high quality pharmaceutical labels do require stringent standards in print quality, material qualification, and 100% print inspection. Additionally, they must be durable and traceable.
DSCSA
Pharmaceutical label printing is crucial to the success of the pharmaceutical industry. Not only must pharmaceutical labels be tamper-proof, but they also need to be easily identifiable and stored in a controlled environment. Manufacturers are increasingly turning to barcodes and randomized tracking numbers to create a more secure label. These innovations make it much more difficult for counterfeiters to copy labels. Print-and-apply machines are also an option for generating unique information for each pharmaceutical container.
Videojet Technologies has developed technologies for coding and marking pharmaceutical labels to meet the DSCSA regulations. Our technologies enable manufacturers to easily identify their products and manage their supply chains. In addition, our solutions help pharmaceutical companies meet the various traceability requirements of DSCSA. By integrating these technologies into their manufacturing process, we can help pharmaceutical companies comply with DSCSA regulations and improve the overall quality of their products.
High Image Resolution
Pharmaceutical label printing requires high image resolution and high-quality printing. For this, production printers need to use digital presses that can produce labels with resolutions of up to 1200 dpi. To ensure label authenticity, pharmaceutical companies can use advanced finishing techniques like micro-text and advanced watermarking.
A 2D barcode is another DSCSA requirement. This identifier is part of the packaging and labeling of prescription medicines, including those that do not have FDA approval. In addition, the product identifier has to be part of the labeling and registration process. A linear barcode is not acceptable in place of a 2D matrix barcode. A 2D matrix barcode includes the NDC number. Detailed examples of packaging for different products are provided in the draft guidance.
Patient Counseling Information
If you want to include patient counseling information on pharmaceutical label printing, you need to adhere to the regulations set by the Food and Drug Administration (FDA). These regulations dictate how much information should be included on pharmaceutical labeling, as well as the format of the information. These guidelines ensure that the information is legible and easy to understand.
The most common items on a pharmaceutical label are the drug name, warnings, and pharmacy logo. However, the content of these warnings and instructions varies by pharmacy. For example, a label for a prescription medicine from a local pharmacy might have the same information as a label for a prescription from a different pharmacy.
Required NABP
The National Association of Boards of Pharmacy (NABP) has recommended that a pharmaceutical label contain the name of the drug product dispensed, the strength of the product, the manufacturer or distributor, the number of refills, and the pharmacist’s name or initials. Pharmacists are also encouraged to include the date of expiration for the drug product, if applicable.
For this purpose, manufacturers must consider the colour, contrast, positioning, and spacing of the label, which should not be distracting to the patient. In addition, the font size should not be too large, as it may hinder a patient from reading the information on the label.
Serialization Numbers
Serialization numbers on pharmaceutical label printing are important to ensure product safety. Pharma manufacturers must adhere to strict guidelines in order to properly assign and manage these numbers. To do so, they must adapt their packaging processes and establish new serial number management and storage procedures. In addition, pharma companies must also adhere to government regulations.
The FDA has issued guidance for the use of serialized numbers on pharmaceutical label printing. The guidance, however, does not make authenticating drug packages any easier. While it endorses the GS1 standard, it does not make the process easier. Manufacturers are concerned about the costs and technology requirements involved in implementing SNI. In addition, they will need to hire more manpower to implement the new system.
The Use of Serialization Numbers
The FDA promotes the use of serialization numbers on pharmaceutical label printing in order to combat counterfeiting and other forms of fraud. It also provides a means for manufacturers to trace products from their factory to their customers. This helps them better understand demand and plan future production runs. This is a crucial step in preventing pharmaceutical errors.
Because the pharmaceutical industry has such a complex supply chain, manufacturers need to generate unique product identifiers for each product. These identifiers help companies monitor and supervise complex logistics operations. Furthermore, serialization helps prevent the sale of counterfeit drugs and keeps patients and regulators safe.
Films
Films for pharmaceutical label printing are designed for a wide range of purposes. They can be used for multicolor pressure-sensitive labels, waterproof laminations, and more. These labels can be placed on a variety of items, including bags, stick packs, and sachets. They have a glossy finish and are available in a variety of colors and materials. They can also have decorative foil stamping to increase the quality of the printed information.
In pharmaceutical label printing, films are used to ensure the quality and consistency of the product. Films are available in a variety of types and can be made from a variety of materials, including PET+LDPE and PVC/PE/EVOH/PE. In addition to printing pharmaceutical labels, films are also used for packaging pet food and aeronautics applications. Choosing the right film can help you ensure the product you are selling is both efficient and attractive.
Range of Film Materials
Innovia Films offers a range of film materials to meet pharmaceutical label printing requirements. Its BOPP films are ideal for labelling across containers and have excellent dimensional stability. Moreover, Innovia Films offers a range of printable coatings for pharmaceutical label printing.
API dosing is controlled by the concentration of the ink API, the number of layers, the printed area, and the resolution of the film. Each adjustment has individual advantages and disadvantages. For example, the ink concentration is limited by the solubility of the API, but it can be adjusted by adding different concentrations of the API in different layers. Inks that have an increased MPT content may be more suitable for pharmaceutical label printing.
Traceability
Pharmaceutical manufacturers have a growing need for traceability. As modern distribution networks are extensive and cross international boundaries, it’s crucial to be able to trace products back to their source. With traceability, pharmaceutical companies can prevent grey market trade and detect counterfeit products. Increasingly, manufacturers are turning to technology for help.
New legislation in the US requires unique coding on drug packs that can track active ingredients from their manufacturer to the user. This allows manufacturers to track their products from the source to the consumer, ensuring the safety of the drug. It also helps track the supply chain and weeds out grey imports. Ultimately, it can identify counterfeit drugs, helping the pharmaceutical industry maintain a safe supply chain.
Critical Component
Traceability is a critical component of pharmaceutical label printing and plays an important role in the safety and quality of a product. It allows for faster recalls and helps distribution and store workers identify products that may be unsafe for human consumption. By providing a clear traceability history, manufacturers can protect their customers and improve their processes.
Pharmaceutical label printers can implement traceability throughout the manufacturing process. Using ECM suites, label printers can automate the creation and distribution of reports. This saves manufacturers time and money.
Cost
The cost of pharmaceutical label printing can vary widely, depending on a number of factors. For example, pharmaceutical labels can have Braille printing, extra thick booklet labels, and other special cuts. Additionally, there are special rules for the design and placement of the label. These factors can all increase the cost of the label. In addition, different types of medications require different types of labels. It is important to choose a label printer that has experience in this field. This will reduce the chance of errors and save you both time and money.
The cost of pharmaceutical label printing depends on the substrate used. There are various types of labelstock used by the pharmaceutical industry, but there are some that are more info for expensive than others. Pharmaceutical manufacturers need to choose a substrate that fits the container they are using. Ideally, they want a paper or film that is both high-quality and inexpensive.
Another important factor in pharmaceutical label printing is quality control. Using vision inspection systems and bar code scanning is essential to ensure the quality of the printed labels. A single millimeter difference can pose a major risk. The last thing you want is to find out that the label is missing a period of 1.5 mils!
