The Importance of Serializing Packaging for Pharmaceutical Products

Serialization is crucial in the pharmaceutical industry because it enables the verification of drug authenticity. Assigning a distinct serial number to each product allows manufacturers to create a verifiable record of its batch number, origin, expiration date and other key information about the drug. This empowers the health care industry and patients to verify a medication’s legitimacy to protect against counterfeiting, diversion or theft of a pharmaceutical product.

If you are a professional in the pharmaceutical industry or clinical research, learn what serialization is, its benefits and how different types of serialized packaging effectively work to document pharmaceutical products.

What Is Serialization in Pharmaceutical Product Packaging?

Serialization is the process of assigning a unique identifier to each pharmaceutical product and its outer packaging — often a serial number or barcode. This system allows tracking and verification of products at every stage of the supply chain, ensuring their authenticity.

The unique code enables manufacturers, distributors and regulators to trace the product’s journey and proactively identify and remove counterfeit or diverted medications before they reach patients. It also helps maintain the appropriate storage and transportation conditions for preserving the integrity of pharmaceutical products.

Over the years, serialization for medicines has become mandatory in many countries. In the United States, the Drug Supply Chain Security Act (DSCSA) requires serialization to help trace prescription drugs at the packaging point and protect patients from counterfeit and harmful medications. Similarly, the European Union’s Falsified Medicines Directive (FMD) requires serialization and verification before medicines reach patients, reinforcing drug and health safety.

By implementing packaging serialization, pharmaceutical companies can comply with regulations while enhancing operational transparency, product accountability and safety in the health care industry. The following are key benefits of serialization in pharmaceutical packaging:

Prevents counterfeit drugs: Serialization ensures each product can be authenticated, making it significantly harder for counterfeit medicines to infiltrate the market.
Improves supply distribution: With unit-level tracking, manufacturers and distributors can gain real-time visibility into inventory, improving logistics and reducing supply chain inefficiencies.
Facilitates easier product recall: Unique serial numbers make it easier to identify and retrieve affected products quickly and accurately in case of a recall.
Provides data for manufacturers: Serialization generates valuable data that can help manufacturers improve distribution, analyze market trends and derive insights to make more informed decisions.

What Is a Patient Information Folded Leaflet?

A patient information folded leaflet is a printed document with medication packaging that provides essential details about the drug. It contains information such as dosage instructions, potential side effects and warnings to ensure patients use the medication safely and effectively. Patient information leaflets are typically printed on pharmaceutical-grade paper and available in various folding methods and printing options.

A specialized type of patient information leaflet, called serialized topserts, includes a distinct identifier for enhanced tracking and verification.

Serialized and Pre-Serialized Topserts

Beyond anti-counterfeiting measures, serialized topserts serve as a vital communication tool within the pharmaceutical industry. By including detailed information on the formulation and proper administration of the medicine, they effectively inform both health care professionals and patients about its proper use.

For added convenience and integration with existing packaging processes, pre-serialization options are available for folded leaflets. These ensure the necessary information is included with the serialized packaging and can be secured using adhesive or a c-clip, a small label securing the folded leaflet.

The difference between a serialized topsert and a pre-serialized topsert lies in when the serialization process occurs:

Serialized topsert: The unique code is printed during the printing process of the topsert, as part of the manufacturing of that specific product or batch.
Pre-serialized topsert: The distinct code is printed on the topsert beforehand, marking it ready to be attached to a product.

Topserts offer patients convenient access to crucial medication details, eliminating the need to read a separate leaflet. Mounted directly to the bottle, they ensure information is readily accessible. Unlike detached leaflets, topserts are less prone to loss or misplacement, remaining securely attached to the medication container. This enhances patient adherence and reduces the risk of dosage errors by keeping essential instructions available.

CCL Healthcare offers topsert packaging serialization designed for efficient integration into your packaging process. Our topserts come in a compact folded design for easy application on top of bottles. To further streamline production, our topserts are preloaded when delivered into trays. We provide various customization options, including:

C-clips
Barcoding
Glued topserts
Finished folded sizes
Panel counts

Serialized Folded Leaflet Topserts

Serialized folded leaflet topserts provide an effective labeling solution for medicine containers, attaching to the top or side of the bottle. These compact, multi-language instructions for use (IFUs) deliver important medication details in an easily readable format.

One of its main features is the inclusion of variable data, such as a QR code, barcode and a unique serialized number, enabling enhanced tracking and inventory control for each IFU. This approach to labeling is a key component of serialized packaging, ensuring product authenticity and traceability.

These topserts can be customized with essential information like dosage, administration instructions, warnings and expiration dates, providing accessibility for health care workers and patients. The compact design maximizes space on pharmaceutical bottles, offering better product organization while reducing the potential for medication errors.

Leaflet Customization Options From CCL Healthcare

CCL Healthcare offers a comprehensive range of pharmaceutical patient information leaflets, including leaflet inserts and outserts printed on pharmaceutical-grade paper with diverse color options and folding methods. Manufactured in Current Good Manufacturing Practices (cGMP) facilities according to International Organization for Standardization (ISO), our leaflets undergo 100% electronic verification to uphold top quality and accuracy.

CCL Healthcare’s serialized topserts and other pharmaceutical patient information leaflets provide an efficient, cost-effective solution for delivering crucial information to health care professionals and patients. Our service helps fight counterfeit medicine while safeguarding the public’s health and safety.

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Serialized Topserts Leaflets

Patient Information Folded Leaflets

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Serialized Topsert

Serialized topserts are a powerful tool to combat counterfeiting in the pharmaceutical industry. By assigning a unique serial number to each topsert, it becomes possible to track and trace the topsert and its corresponding product throughout the supply chain. CCL Healthcare offers pre-serialization options for both the leaflet and the c-clip, allowing for flexibility in meeting customer requirements.

Our topserts are compactly folded, making them easy to affix on top of bottles. They are available in various finished folded sizes, panel counts, and finishing options like c-clips, barcoding, serialization, and glue. Topserts are delivered preloaded into trays, which streamlines the packaging process and ensures efficiency in the production line.

Topserts Folded Leaflet Overview

Serialized Topsert Instructions for Use (IFUs) is a labeling solution for pharmaceutical bottles that can be mounted to the top or side of the bottle. It is a multi-language, mini-folded IFU that contains important information about the medication in a compact and easy-to-read format.

One of the key features of Serialized Topsert IFUs is the inclusion of variable data such as a barcode, QR code, and/or serialized number. This unique identifier is specific to each IFU and allows for better tracking and inventory management of medication.

Serialized Topsert IFUs can be customized to include specific information about the medication, such as dosage, administration instructions, warnings, and expiration date. They can also be printed in multiple languages, making them accessible to a wider range of patients.

The compact size of Serialized Topsert IFUs makes them ideal for pharmaceutical bottles, as they do not take up much space and can be easily attached to the top or side of the bottle. This allows for better organization and identification of medication, which can help reduce the risk of medication errors.

Overall, Serialized Topsert IFUs provide a convenient and effective solution for pharmaceutical labeling, allowing for better tracking and management of medication while also providing important information to patients in a compact and easy-to-read format.

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Why CCL Healthcare for Folded Leaflets

Our pharmaceutical and Healthcare leaflets are printed and folded with the most advanced equipment available in the industry. Pairing our highly trained and qualified staff with our robust SOP’s and cGMP facilities allows us to exceed our CCL Healthcare is a leading provider of printed leaflets for the pharmaceutical and healthcare industry. With over 65 years of experience, CCL Healthcare specializes in producing leaflets that contain vital patient and physician information, such as side effects, instructions for use, and directions for use. These leaflets are available in various formats, including inserts, topserts, sideserts, glued pads, neck hangers, and more.

CCL Healthcare uses state-of-the-art printing and folding equipment to ensure that the leaflets meet the highest quality standards. The company’s robust folding capabilities allow for up to 350 panels, giving them the flexibility to design more formats and configurations to meet pharmaceutical challenges. The leaflets are printed on pharmaceutical grade paper and are available in black and white, spot color, full color, and the industry’s largest variety of folding methods, including cross and glued folding.

CCL Healthcare places a strong emphasis on quality. The company invests heavily in vision verification systems and follows strict SOPs and CSPs in fully segregated manufacturing areas. The leaflets are manufactured under cGMP and ISO standards in temperature and humidity control facilities. The company’s dedicated quality assurance team ensures that every product is 100% verified and documented for traceability.

CCL Healthcare has a global presence and manufacturing footprint, with 34+ specialized healthcare sites. Their experienced staff provides the highest level of service, technical expertise, and product innovation anywhere you are. Overall, CCL Healthcare is a reliable and trusted partner for pharmaceutical and healthcare leaflets.customers quality expectations. Our investment in equipment and people have allowed us to continually be the market innovators and grow our leaflet and printed literature offerings to meet the unique challenges that the pharmaceutical and healthcare industry demands.

When it comes to quality, CCL Healthcare is the market leader investing heavily into vision verification systems and establishing the standard for pharmaceutical printing in the industry. The standard includes ensuring every product is 100% verified and documented for traceability. We manufacture under cGMP and ISO standards in temperature and humidity control facilities. Our dedicated quality assurance team and production departments follow strict SOPs and CSPs in fully segregated manufacturing areas. Our global presence and manufacturing footprint allows you to go global with 34+ specialized healthcare sites. Our experienced staff provides the highest level of service, technical expertise, and product innovation anywhere you are.