In the pharmaceutical industry, ensuring the safety and authenticity of medications is a critical concern, and the packaging sector plays a pivotal role in this endeavor. The implementation of robust Pharmaceutical Track and Trace (T&T) best practices in packaging is essential for enhancing supply chain visibility, combating counterfeiting, and adhering to regulatory requirements. This article explores the significance of T&T best practices in the packaging industry and their crucial role in upholding the integrity of pharmaceutical products.
Enhancing Supply Chain Visibility
The pharmaceutical supply chain is a complex network involving multiple stages, from the manufacturing of medications to their distribution and delivery to end-users. T&T best practices in packaging contribute to enhanced supply chain visibility by incorporating technologies such as barcodes, QR codes, and RFID tags. Each unit of pharmaceutical product is assigned a unique identifier, allowing for precise tracking throughout its journey.
This visibility is invaluable for stakeholders across the supply chain. Manufacturers can monitor the movement of products in real-time, enabling them to optimize production schedules and respond promptly to any disruptions. Distributors and wholesalers benefit from accurate information on inventory levels, allowing for efficient stock management. Pharmacies and healthcare providers can track the expiration dates of medications, reducing the risk of dispensing expired drugs.
Counterfeit pharmaceuticals pose a significant threat to public health, and the packaging industry plays a key role in preventing their infiltration. T&T best practices involve the serialization of pharmaceutical products, where each unit is assigned a unique identifier that is recorded at each stage of the supply chain. This serialized data can be accessed by stakeholders and, importantly, by consumers.
Pharmaceutical packaging with integrated T&T features allows end-users to verify the authenticity of their medications. By scanning a barcode or QR code on the packaging, consumers can access information about the product’s origin, manufacturing date, and distribution route. This transparency not only empowers consumers to make informed choices but also acts as a deterrent to counterfeiters, who are less likely to succeed when faced with such rigorous scrutiny.
Ensuring Regulatory Compliance
The pharmaceutical industry is subject to strict regulatory requirements to ensure the safety and efficacy of medications. Packaging plays a crucial role in helping pharmaceutical companies adhere to these regulations. T&T best practices, especially serialization, are often mandated by regulatory authorities worldwide.
By implementing T&T features in packaging, companies not only comply with regulatory requirements but also demonstrate their commitment to quality and safety. Failure to meet these standards can result in severe consequences, including legal penalties and damage to a company’s reputation. Packaging that integrates T&T best practices ensures that pharmaceutical companies operate within the framework of global regulations, fostering trust among regulatory bodies, healthcare professionals, and consumers.
Responding to Recalls and Quality Issues
In the unfortunate event of a product recall or the identification of a quality issue, T&T best practices in packaging enable rapid and targeted responses. In the past, broad recalls were often necessary to address concerns about product safety, leading to significant financial losses and potential harm to patients.
With advanced serialization and traceability features, pharmaceutical companies can pinpoint the specific batches affected by a recall. This targeted approach minimizes the impact on the supply chain and reduces the number of products that need to be removed from circulation. T&T in packaging allows for a more efficient and precise response to quality issues, mitigating risks and protecting both public health and a company’s bottom line.
Pharmaceutical Track and Trace best practices in the packaging industry are indispensable for safeguarding medications, ensuring regulatory compliance, and maintaining the integrity of the pharmaceutical supply chain. By enhancing supply chain visibility, combating counterfeiting, and facilitating rapid responses to recalls and quality issues, T&T features in packaging contribute significantly to the overall safety and efficacy of pharmaceutical products. As technology continues to advance, the integration of sophisticated T&T solutions in packaging will remain crucial, supporting the pharmaceutical industry in its commitment to delivering safe and genuine medications to patients worldwide.
Pineberry offers Serialization, Aggregation and Track & Trace solutions for the Pharmaceutical industry that are inline with the Drug Quality & Security Act. We offer date and lot coding, leaflet and instruction manual insertion, bar coding and verification, and more. For more information, review our pharmaceutical product page.
The global packaging industry is on the verge of experiencing a significant transformation in 2024, driven by evolving consumer preferences, technological advancements, sustainability concerns, and the ever-expanding e-commerce sector. As we navigate a world that continues to change rapidly, the packaging industry is poised to play a pivotal role in shaping the future. In this article, we’ll delve into the key factors driving the anticipated growth of the packaging industry in 2024 and the trends that will define its landscape.
Sustainability Takes Center Stage
One of the most pronounced trends in the packaging industry for 2024 is the continued emphasis on sustainability. As consumers and governments increasingly demand eco-friendly packaging solutions, companies are investing in more sustainable materials, innovative designs, and circular economy practices. Expect to see a surge in biodegradable and recyclable packaging materials, as well as reduced single-use plastics.
The rapid growth of e-commerce is reshaping the packaging landscape. With more consumers shopping online, there’s a heightened need for efficient and protective packaging solutions. This growth isn’t limited to traditional goods; the food delivery and meal kit industries are also experiencing unprecedented expansion. This shift is creating a demand for packaging solutions that not only safeguard products during transit but also enhance the unboxing experience.
In 2024, technology will continue to play a significant role in the packaging industry. Augmented reality (AR) and virtual reality (VR) are becoming more integrated with packaging design, offering interactive and engaging experiences for consumers. QR codes and near-field communication (NFC) tags on packaging will enable customers to access product information, promotions, and even exclusive content.
Moreover, the industry will see the growth of smart packaging, which incorporates sensors to monitor product freshness, temperature, and more. This real-time data can be transmitted to consumers, ensuring product quality and safety, and providing valuable insights to companies.
Personalization and Branding
Personalized packaging is becoming a crucial element of the customer experience. Brands are using packaging to establish a connection with consumers by offering customizable packaging options, limited-edition designs, and even user-generated content on packaging. This trend extends to luxury goods, as well as mainstream products, as companies recognize the importance of differentiation and brand loyalty.
“Eco-packaging” is a term that encapsulates the fusion of ecological and technological advancements. Packaging companies are increasingly utilizing AI and machine learning to optimize packaging designs and materials, reducing waste and enhancing efficiency. Expect to see more adaptive packaging solutions that can be customized on-demand, ensuring minimal waste and maximum functionality.
Governments worldwide are implementing stricter regulations on packaging materials to combat environmental concerns. Companies will need to adapt to these changes by investing in sustainable alternatives, reducing plastic usage, and improving recycling practices. The focus on Extended Producer Responsibility (EPR) is growing, meaning manufacturers are being held more accountable for the full life cycle of their packaging.
In 2024, the packaging industry stands at the precipice of remarkable growth, driven by sustainability, e-commerce, technological advancements, personalization, and regulatory changes. Companies that successfully navigate these changes and adapt to the evolving landscape will not only thrive but also contribute to a more sustainable and customer-focused future.
As consumers continue to prioritize environmentally responsible products, packaging companies will play a pivotal role in shaping the future of the consumer goods industry. The packaging industry in 2024 is not just about protecting products; it’s about delivering innovation, convenience, and a more sustainable future for all.
Do you rank among those who need to respond to the difficult task of implementing serialization of pharmaceutical’s?
Pharmaceutical Executives are hustling to finalize plans to execute the Drug Quality & Security Act, which became law on November 27th, 2013. The supply chain for genuine pharmaceuticals has grown longer, and every step in the chain offers an opportunity for counterfeiters. The problem of counterfeit drugs and drug adulteration has been a worldwide issue for decades. Driven by e-Commerce sales, unsecured physical and cyber global supply chains, and minimal criminal charges, counterfeit prescription drugs have become an exploding industry with an estimated market worth of $75 billion a year worldwide.*
Four reasons why serialization solutions are important to the pharmaceutical supply chain.
Track and Trace Pharmaceutical Products Throughout the Supply Chain
The Drug Quality & Security Act requires product serialization codes to be added to each pharmaceutical package for unit level traceability. These measures are positioned to deal with suspicious and illegitimate products. Manufacturers, wholesale distributors, dispensers and repackagers must pass, capture, maintain and update information with respect to each transaction. Information that must be recorded includes the name of the product, strength and dosage form, NDC, container size, number of containers, lot number, transaction date, shipment date, and the name and address of the business previous and subsequent owner. To elaborate, product tracing requirements are triggered by changes in ownership/transactions between trading partners. Each business is required to provide the transaction information, history, and statement to the subsequent owner for each transaction, and capture and maintain for six years.
Reduces Counterfeit and Drug Adulteration
80% of counterfeit drugs come from overseas, most of them manufactured in India and China. With the high price of prescription drugs and the relative ease of duplication and diversion make them a prime target for counterfeiters. Pharmaceutical companies and governments worldwide believe that counterfeiting can be reduced significantly by implementing product serialization, hence the Drug Quality & Security Act. The act requires pharmaceutical products and packages to be equipped with product serialization codes for ease of traceability. Serialization requires a comprehensive system to track and trace the passage of prescription drugs through the entire supply chain. Serialization identifies every product within a supply chain by a unique serial number, in addition to the origin, shelf life, and batch number. Serialization can also trace the pharmaceutical product from production through distribution to patient.
Provides Visibility and Full Traceability
Substantiation of pharmaceutical products at various levels in the supply chain becomes very difficult without data sharing across the supply chain. Controlling and monitoring a highly complex distribution network from manufacturer to consumer in which products change hands as many as 10 times is easier said than done. Serialization requires collaborative action from partners throughout the supply chain for accurate recordings, tracking and managing data as the product moves from manufacturer, to distributor, to the consumer.
Reduces Overall Cost of Pharmaceutical Products and Medications
Current business processes in the pharmaceutical and its supply chain industry is very labor-intensive. As a result, the price paid by the consumer for pharmaceutical products is very high. Automating greatly reduces labor costs, and improves efficiency, cutting costs. We at Pineberry Manufacturing offer many automated serialization and track and trace options for the pharmaceutical industry. Visit our Pharmaceutical Packaging & Serialization webpage for more information.
As part of a long-term strategy, the United States has been trying to move to implementing technology and systems that would discourage the introduction and distribution of counterfeit drugs. In November 2013, President Obama signed into law the Drug Quality and Security Act. This act is the result of a multi-year effort to produce balanced legislation taking into consideration stakeholder priorities. Implicit within the Drug Quality and Security Act outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the U.S.
Nearly everyone is familiar with plastic, bank, gift and key cards. However, you might not be up to date on the trends driving innovation within the plastic card CR80 manufacturing industry. From increased security by government agencies to widespread adoption by public transit systems, new areas of growth are diversifying the industry.
Plastic cards have taken the gift card industry by storm over the last decade. Incentive Magazine reports that more than 77% of American consumers have given gift cards in the past year and more than 90% have used at least one. Add to that hotel room key cards, promotional and customer loyalty key tags, membership cards, ID cards, driver’s licenses, and other popular card uses, a very large market begins to emerge.
Four industry specific plastic card manufacturing trends:
Government and Healthcare
The need for secure IDs, driver’s licenses, passports, healthcare access and patient cards is growing year over year. Government and healthcare sectors have a high need for security and privacy. The need for more sophisticated technology to protect card users and integrate card functions is a major drive for innovation moving forward.
Financial and Banks
The global financial card market continues to expand, creating growth driven by dual interface technology and the shift to debit and prepaid cards. New EMV chip card technology is now becoming the standard in many countries. Although mobile payment options are becoming more common, they have a long way to go and many smartphone payment applications require a companion card.
You may not associate public transportation with plastic cards, but that will change. According to the International Card Manufacturers Association (ICMA) one of the biggest card manufacturing trends is in the public transportation sector. The move from paper based tickets to contactless smart cards is growing in popularity and will likely continue to grow as public transportation systems grow in demand.
The gift card market is well saturated, but growth continues, especially during holiday seasons. According to Gift Card Granny, American consumers spend over $100 Billion on gift cards annually. Increasing acceptance of gift cards in Asian markets is also driving growth in the plastic gift card market. The volume of gift card usage in Asia increased at an average annual growth rate of 24% during 2010-2015, to 230 million in 2015.
Plastic cards are bringing security, convenience, and reliability to many industries. Their continued popularity in multiple industries will increase innovation, specifically in these four key markets.
A large science and medical laboratory contacted Pineberry Manufacturing Inc., Toronto, Canada, to serialize its products and support traceability throughout its supply chain to comply with the Drug Supply Chain Security Act (DSCSA) in the U.S. The problem: Limited space necessitated a compact system to print serialized codes on flat pouches and cartons.
A few weeks later, the CartonTrac FC – Flat Carton Serialization System was delivered. Measuring 60 in. long and 32 in. wide, flat cartons are placed on the Pineberry HSF 12 friction feeder and dispensed singly on a vacuum conveyor, which passes a drop-on-demand inkjet printer for application of variable serialized data. An integrated camera system verifies code data before the printed blanks drop into a catch tray.
“CartonTrac flat carton and erect carton serialization systems are available as turnkey systems or as specialty feeding units integrated to existing structures,” says David McCharles, president of Pineberry Manufacturing. “Our ability to adapt to a large, changing industry with heavy regulations has made us a trusted manufacturer in pharmaceuticals and packaging industries,” he notes.
He explains, “The Pineberry CartonTrac Serialization Series marks flat and erect cartons, bags and leaflets to add track-and-trace information, barcodes, date and lot codes, UDI codes, labels, inserts and much more. Our serialization systems produce the cleanest codes on the market, verified with an in-line reader and cannot be tampered with. Cartons are controlled with precision.”
With longer supply chains and rising e-commerce sales providing more opportunities for counterfeiters, regulations to serialize and trace products are or soon will be in place in more than 40 countries. Deadlines set to comply with U.S.’s DSCSA and the European Union’s Falsified Medicines Directive 2011/62/EU (EU-FMD) are fast approaching in 2017 and 2019, respectively. Pharma companies, contract manufacturers and contract packagers should already be taking steps to ensure lines are serialization-ready.
Centralized serialization room servicing packaging lines and rework stations is equipped with easily deployable serialization and track-and-trace software.
Tris Pharma, a specialty pharmaceutical company that does research, development, and manufacturing of over-the-counter and prescription branded and generic products, has selected software from Adents to assure compliance with upcoming U.S. serialization deadlines.
Adents provides serialization and track-and-trace software, and its solution was chosen by Tris Pharma over a variety of competing options.
For the new venture, Tris Pharma designated a centralized serialization room servicing packaging lines as well as rework stations. The dedicated serialization suite will provide track-and-trace solutions for customers such as Pfizer, Vernalis, and Breckenridge.
The Adents serialization and aggregation suite of software enables companies to achieve traceability and documentation compliance easily, addressing both current and emerging regulations while also minimizing impact on production processes and productivity. Adents software is flexible, scalable, and quick to deploy because its configuration takes place completely at the site level, making per-line configuration unnecessary. It also helps enrich marketing and eliminate counterfeiting.
Adents serialization software is hardware-agnostic, compatible with a wide range of equipment. At Tris Pharma, the dedicated serialization suite contains a Pineberry Manufacturing Flat Carton mark and verify unit for cartons, and a mark and verify labeler from Weiler Labeling Systems. Both machines will employ laser marking, DataLase coatings, and Cognex smart cameras for inspection.
Although full implementation of 2013’s Drug Supply Chain Security Act will be phased in over the next decade, the next milestone for manufacturers is November 27, 2017, by which date pharmaceutical manufacturers are required to print a unique product identification code on all Rx units of sale and homogenous cases distributed domestically.
Due to Tris Pharma’s GMP procedures, the centralized serialization room will be limited to production of either labels or cartons at any given time. As Tris expands, however, it likely will house the Weiler and Pineberry units in separate rooms, enabling them to run simultaneously.
“One of the reasons we chose Adents is that its solution is both versatile and scalable,” says Brian Weiss, Associate Director of Engineering for Tris Pharma. “The flexibility offered through Adents allows us to comply with the short-term serialization mandate while remaining adaptable for both future regulations and evolving business needs.”
Currently, each of the four prescription packaging lines serviced by the serialization suite has two aggregation stations, for manual unit-to-case aggregation and manual case-to-pallet aggregation, respectively. Products from Tris Pharma are typically shipped as whole batches to customers and third-party logistics providers.
Moving forward, Tris Pharma also has plans to automate work order entry. At present, the company handles work order entry manually, but is looking to migrate to JD Edwards-generated work orders upon the ERP system’s completion. With the aid of an Adents Supervisor platform, whose function is to manage and distribute serialized codes, the enhanced setup will significantly ease the exchange of serialization data.
“We are so pleased Tris Pharma will be using Adents serialization software to help it comply with serialization deadlines,” says Christophe Devins, CEO of Adents, “and are confident the company will quickly see evidence of the effectiveness, flexibility, and ease-of-use of our modular software.”