Track & Trace

RxGPS provides guiding principles for implementation of effective serialization requirements and a sample timeline of an appropriate, phased implementation process.

On February 9 2019, the 2011/62/EU Falsified Medicines Directive introduced the obligation to attach safety devices on medicines to prove their integrity and authenticity. The Directive proposes measures to make the European Union (EU) medicine supply chain safer. For its part, the Delegated Regulation (EU) 2016/161 outlines the provisions within the Directive.

New survey finds pharmaceutical companies concerned about supply and demand, visibility

Drug shortages, cost-cutting pressures, demand for generics, and increased online buying further fuel the sale of counterfeit drugs. This not only leads to the loss of billions of dollars, but also increases health risks and recalls, tarnishing the brand image of the already struggling pharmaceutical industry. Track and Trace (T&T) is a new solution that can help pharmaceutical companies effectively manage their supply chain and mitigate the risks associated with counterfeit drugs.

Serialization is increasingly becoming a necessity for the pharmaceutical industry due to complex distribution networks, the need for product authentication, current and future regulatory requirements, as well as to protect the brand and increase consumer confidence in medicine.
Therefore, it will significantly impact the future strategy of pharmaceutical companies and forthcoming developments in the life science industry.

Nowadays due to smartphone penetration, serialization not only helps in supply chain visibility but also helps in consumer engagement and loyalty, and enables a lot many digital capabilities which were not possible before, thus making it very desirable to use it on almost every product in every industry, to increase consumer retention and repeat sales.

A key concern for pharma manufacturing companies is that the large investment and increased production cost associated with implementing advanced serialization solutions will increase unit cost. This is a very valid concern. However, the global serialization legislative changes may be the best possible starting point for improving your packaging process.

Although the list of cell and gene therapies is growing, prices remain high. Now developers are working on a road map to streamline production and drop costs

Chinese healthcare has been ridden with problems such as inefficient tracking systems for medicines and a paper-heavy approach to recording patient information. As a result, there’s a risk of records being tampered with or incomplete. By authenticating prescription information and being able to trace it back to the doctor who issued it, the medicine dispensing process becomes more secure and pharmacists are more confident that the medicines they dispense are for legitimate use.

Serialization is the process of assigning and applying a unique identification code to a product. Aggregation defines the relationship between multiple items within a product shipment, such as cartons, cases, and pallets.
Together, these two concepts form the foundation of “Track-and-Trace,” which documents a product’s current and past locations throughout the supply chain. This ability to track a product’s whereabouts and trace its path is the start of a safer and more efficient drug supply chain.

The war against counterfeiting, mal-practices, and product defects, in order to protect the consumer, has escalated over the years. The introduction to GS1 to manufacturing and distribution process, has provided some ways to empower the consumer and end user, but introduces more complexity and difficulty for businesses and brands. Especially with the expansion of global trade and manufacturing, this has been alarmingly difficult.

Every year drug recalls occurs routinely. The product recall is resorted to if there is evidence that the use and the continued presence of a batch of a product on the market presents a risk to the health of the user or a local regulatory authority directs a recall. A company must, therefore, have a system for speedy and efficient removal of unsatisfactory material from the market. There should be a written procedure that must define-who is responsible for deciding to initiate a recall and how the product, including samples, can be traced and removed from the market.

A batch of popular painkillers has been pulled from pharmacy shelves after another medication that is four times stronger was found in one packet.

A national safety alert was issued following several incidents, including the deaths of two babies at hospitals in England, in which patients were inadvertently given a dose of sodium nitrite - which is used as an antidote to cyanide poisoning - rather than sodium bicarbonate.

The major markets for pharmaceuticals have been forever transformed with the arrival of mandated serialization. With both the United States Drug Supply Chain Security Act (DSCSA) and European Union Falsified Medicines Directive (FMD) now “live”, the pharmaceutical supply chain is forever tied to serialized products and data. When looking deeper, a successful serialization program involves far more than just placing serial numbers on packaging.

Fountain Run, KY, Apace Packaging LLC is voluntarily recalling one lot of Acyclovir Tablet, USP, 400mg, 50ct Unit Dose, NDC# 50268-061-15 (Carton), NDC# 50268-061-11 (Blister Card), Lot Number 19900, to the Retail level. These products have been recalled due to a product mix-up. A small number of blister cards containing Acyclovir Tablets, 400mg, UD Blister Cards may potentially also include Torsemide, 20mg, Tablets.

The cartons for tranexamic acid injection, packaged in boxes of 10 single-dose 10-milliliter vials, may contain vials of amiodarone, while the affected amiodarone-labeled cartons—sold in packages of 10 single-dose 9-milliliter vials—may contain vials of tranexamic acid, Mylan said in a release.

Aux États-Unis, la Loi sur la sécurité de la chaîne d’approvisionnement des médicaments (DSCSA) a rendu obligatoire la sérialisation unitaire en novembre 2018. Grâce à cette nouvelle règlementation, de plus en plus d’entreprises réalisent à quel point la sérialisation et la conformité peuvent être efficaces et potentiellement rentables. Même si l’agrégation ne devrait devenir obligatoire et être entièrement implantée qu’en 2023, selon la FDA aux États-Unis (Administration des aliments et médicaments), il serait plus réaliste d’affirmer que la plupart des fabricants et les compagnies pharma les plus influentes seront prêts bien avant la date limite, ou qu’ils ont déjà implanté un système de traçabilité interopérable avec leur processus de sérialisation. Cette transparence intégrale permettra d’empêcher que les produits contrefaits et frauduleux ne pénètrent dans la chaîne d’approvisionnement améliorée du secteur de la santé, ce qui fera en sorte d’assurer la sécurité des patients partout dans le monde et de rétablir la confiance dans l’industrie pharmaceutique.

Reed-Lane, a New Jersey-based contract packaging provider serving leading pharmaceutical manufacturers, has introduced its second Track & Trace-ready cartoning line for unit-level serialization and multi-level aggregation. The line debuts as pharma companies look to initiate aggregation practices well ahead of the looming 2023 DSCSA deadline.

TraceLink has introduced Serialized Product Intelligence (SPI), a cloud-based application that harnesses serialization data to provide actionable intelligence and help optimize supply-chain operation. The technology is designed to help simplify the process of managing serialization data across an option, enabling users to proactively monitor serialized operations, proactively identify supply chain issues, avoid potentially expensive delays, and maintain timely product delivery.

Some manufacturers have responded by adding QR codes and secondary barcodes on packages that connect consumers to more product information. Not only do these extra codes take up valuable label “real estate,” but they may not even contain standardized product identifiers like UPCs, causing confusion when scanning at point-of-sale checkout counters.

Des chercheurs de Microsoft ont créé des « étiquettes moléculaires » à partir de brins d’ADN présynthétisés et déshydratés. Un marquage peu coûteux, infalsifiable et pouvant être intégré à n’importe quel support de manière invisible. De quoi remiser aux oubliettes le sacro-saint code-barres ?

The U.S. Food and Drug Administration (FDA) is taking a critical step to further enhance its nascent electronic track and trace system for prescription drugs, which was established as part of the Drug Supply Chain Security Act (DSCSA) of 2013. The DSCSA authorized the FDA to build an electronic, interoperable track and trace system by 2023 to reduce drug diversion and introduction of counterfeit products into the U.S. drug supply chain.

Laser Glass Engraving machines are machines that use laser technology to mark glass materials. There are various methods currently in use in the industry that make use of laser engravers to mark glass and glass materials.