Track & Trace

Schreiner MediPharm joins DoseID, a consortium seeking RFID tracking standardization in the healthcare sector.

Supply chains are probably the weakest link in complex business architectures. The “just in time” inventory needs of modern consumption, the rampant consumerism, the extreme globalization and connectivity, made supply chains all too complex, fragile and more than ever exposed to sudden shocks. Then came Covid-19 which put supply chains under considerable strain and made their weaknesses and lack of resilience all too apparent.

Comply with drug serialization and reporting requirements – and fight counterfeiting and illicit trade – with Microsoft Dynamics NAV Track and Trace for Pharma. This track and trace software integrates serialization with your processes and provides country-ready reporting packages. Minimize the cost of compliance, manage a secure pharma supply chain, and improve patient safety.

The affected batches of the Danish drugmaker’s NovoMix 30 FlexPen and Penfill may have been subject to a manufacturing problem where prefilled cartridges were subject to either too low or too high a dose of insulin.

To meet the EU serialization deadline on 9 February 2019, pharmaceutical companies and their contractors have had to reorganize their manufacturing lines and logistics to ensure compliance with the EU’s Falsified Medicines Directive (FMD) of 2011 and the EU Commission Delegated Regulation 2016/161 of 2016. Worldwide, other anticounterfeiting regulations are already in place or coming soon in nations including the US, Saudi Arabia, Korea, and Russia. Thus, drug manufacturers that market products internationally must continue to reorganize their operations to comply with many different standards.

Whether serialization deadlines have arrived or are imminently approaching, smaller companies along pharmaceutical supply chains are scrambling to prepare—and for many, it’s a problem.

The product was found to exceed impurity specifications for a known degradant during routine stability testing.

Danish drugmaker Novo Nordisk announced Wednesday it would recall six batches of faulty insulin cartirdge holders used in its NovoPen insulin delivery device due to the potential for the holders to crack or break when exposed to certain chemicals such as cleaning agents.

Traceability at the individual container level can drive quality and production efficiency by preventing product mix-up and improvements in machine utilization, thanks to collected data about rejections.

AvKARE, a generics pharmaceutical manufacturer based in Pulaski, Tennessee, has issued a recall on one lot each of its sildenafil 100 mg tablets and trazodone 100 mg tablets due to a packaging “mix-up” in which both drugs were filled into the same bottle. According to AvKARE, the error occurred at a third-party bottle filling facility. The identity of the facility was not disclosed.

These side-effects could prove dangerous when someone unintentionally takes the drug and then drives a car, for example. We're hoping people aren't out driving their cars while popping erectile dysfunction pills, but who are we to judge.
The two products were unintentionally swapped at a third-party facility, the name of which has not yet been disclosed. The pills have since been distributed nationwide.

The innovation with blockchain-backed traceability will allow better connection between entities with respect to tracking different items. Utilizing this information, organizations would have the option to sharpen their digitization techniques in a rational and very much organized manner.

While that progress has generally centered on procedures, tools and medicines, one digital technology has the potential to completely transform the way healthcare information and data are governed. We’re talking of course about blockchain.

In the last couple of years, there has been a shift in perception when it comes to blockchain technology. Once thought of as being a synonym for cryptocurrencies, blockchain has gradually earned its place as an important emerging technology together with artificial intelligence, big data, and cloud computing. Exciting developments in recent years have attracted interest from various industries, with major and smaller players in those sectors exploring ways to utilize the technology to their advantage. One sector that seems primed for a blockchain-powered overhaul is the pharmaceutical industry. So, let’s discuss blockchain use cases in pharma industry.

Blockchain technology allows different entities in the supply chain to use “cryptographic keys” that provide them with access to specific data subsets. In this case, that goes for everyone from the grower to Avient’s customers, who range between companies in the pharmaceutical, nutraceutical, cosmetics and food and beverage spaces.

Fresenius Kabi is embedding packaging for medications commonly used in the operating room with RFID labels. The track-and-trace technology complies with open GS1 global standards and adds an extra layer of patient safety by protecting drug inventories.

Parmaceutical distributor AvKare is voluntarily recalling 100mg sildenafil tablets and 100mg trazodone tablets due to a "product mix-up," the company announced Wednesday. The tablets were "inadvertently packaged together" when they were bottled by a third-party vendor.
Sildenafil is the active ingredient in Viagra, which is used for the treatment of erectile dysfunction. Trazodone is used to treat major depressive disorder.

• For years, retailers have tried to keep pace with evolving consumer demand for an always-on, personalized experience that blends physical and digital
• But many retailers struggle to reach this new future, with hard-wired businesses that are unable to rapidly and affordably respond to constant change
• With the cloud at the core, retailers can cost-effectively, continually and sustainably innovate to provide the right retail experience in the moment
• The important question to ask about cloud is not about costs, but how cloud can enable an adaptive retail business that can change, innovate and grow.

Meditect a levé 1,5 million d'euros pour développer son application mobile permettant de vérifier l'authenticité d'un médicament grâce à la technologie blockchain. Pour l'instant, l'outil est disponible en Côte d'Ivoire chez près de 300 pharmacies partenaires.

Sandoz Canada, already at the centre of a national drug shortage, is voluntarily recalling 57,000 vials of injectable morphine after a box was found to contain another drug mixed in with the painkiller.

Over the past decade, many legislators have prepared laws and regulations that make pharma serialization obligatory. DSCSA in the United States, EU-FMD in the European Union, and ITS in Turkey are the most notable examples. Pharmaceutical manufacturers and other players in the industry face problems from time to time as they try to assure compliance with the requirements of these regulations. In this article series, we will try to explain every aspect of serialization in the pharmaceutical industry.

The pharmaceutical industry defines aggregation as a process in which identification information about a case of products is collected and built upon at every stage throughout the supply chain. Starting at the packaging stage, each individual product receives its own unique serial number before being placed with other serialized units into a case, which is in turn assigned a group number. Depending on the shipment’s journey, this parent-child coding system can be continued, with numbers assigned to pallets and further identification established.

How well are pharmaceutical companies prepared for globalisation? How will drug supply chain change within the next years? What mechanisms are going to stop drug counterfeiters in the future?