Marken, the clinical trial logistics operation with UPS Healthcare, has expanded its global network to support increased demand for its clinical drug supply chain services, particularly for cell and gene clinical trials. Plans for the remainder of 2021 and 2022 will support accelerated demand for mRNA therapies, cell and gene therapies, early access and managed access programs. Expansion plans include new locations, expanded cold chain services and packaging solutions.
Hospitals, or those at the unit of use level, are not within the scope of DSCSA. To remove a tedious, manual tracking implementation process, Fresenius Kabi is implementing RFID tracking. RFID tagging is fairly invisible to packaging line operators through the use of antennas. RFID tagging is not a DSCSA replacement but an addition to 2D data matrix barcodes.
Serialization is when a unique serial number is assigned to each saleable unit of a product which can help in identifying the information of a product’s origin, batch number and expiration date. Track & Trace in pharma is the process of the product’s current and past locations. It tracks the journey of the product within the supply chain and traces all the intermediate stops it takes from manufacturing to the end user.
Beyond Good, a single origin chocolate company, built on a foundation of sustainable and ethically sourced cocoa, will introduce new packaging for its single-origin Madagascar and Uganda bars this autumn. The packaging is designed to highlight unique properties of single-origin cocoa. Working with global packaging and brand experience company SGK, the company is shifting its descriptors from heirloom to single-origin to increase awareness of the unique flavors in each country’s cocoa, created by genetic varieties and local environmental conditions.
Microtrace has patent-pending technology which integrates with FMCG smart-device consumable systems to identify genuine consumables from low cost generics, private label or counterfeit alternatives and provide real-time consumer behaviour data, plus actionable market intelligence, it says. To determine whether genuine or unlicensed consumables are being used with the smart-device, authentic products are identified using the company’s two-part key authentication, consisting of a taggant signature and/or optical pattern such as a barcode.
myHealthbox is the largest, independent, source of digital healthcare information, providing freely available, trustworthy data for both consumers and professionals. myHealthbox gives companies a unique platform for simple and interactive sharing of healthcare information regardless of device or geography.
Track and trace for pharmaceuticals lets you to pinpoint any item’s current and past locations in your supply chain. It’s a powerful tool that no pharma company can do without, especially as regulations mandate track and trace capabilities and specific requirements for recording and sharing supply chain data.
A new report launched by SharpEnd, an experience-led full-service partner to some of the world’s biggest brand owners across connected packaging and retail, reveals why consumers engage with connected packaging using different technologies such as QR, NFC and AR - unearthing some surprising consumer trends and attitudes.
GS1 US defines traceability (in healthcare) as the process that “enables you to see the movement of prescription drugs or medical devices across the supply chain. You can trace backwards to identify the history of the transfers and locations of a product, from the point of manufacture onwards. And you can track forwards to see the intended route of the product towards the point of care.”
While GS1 Standards have created a hierarchy that reaches down to the product level for serialization, several industry entities have voluntarily chosen to use GS1 EPCIS even as this standard evolves to fully meet the intent of the regulation. EPCIS allows trading partners to exchange data, in concert with the products as they move through the supply chain. An industry pilot between Johnson & Johnson Supply Chain (JJSC) and AmerisourceBergen Corporation (ABC) did just that with actionable and repeatable results.
The main benefits that QR codes can yield include increased customer engagement, easier access to information by customers, and an increase in conversions for businesses. Implementing them into your campaign can give you an edge over competitors who are not utilizing these forms of advertising yet.
Wilmington, MA, Azurity Pharmaceuticals, Inc. (“Azurity”) is voluntarily recalling one lot of Firvanq® (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit (“Firvanq®”) to the consumer level, as some products in the affected lot have been found to incorrectly contain a First Omeprazole (FIRST-PPI) diluent instead of the Firvanq diluent bottle.
If you are a pharma manufacturer and/or CMO and have a rising problem with your current serialization solution provider, you really need a backup solution. Watch on-demand this 30-minute webinar and find out our proposal for better protection of your production efficiency.
Due to the complex nature of the industry, the steps are small but definitive towards sustainable packaging. It`s important to mention that the environmental impact of pharma packaging is small compared with other daily emissions. However, the pharmaceuticals implement different types of green policies and environmentally sound technologies to reduce their environmental impact. Because SoftGroup encourages and supports the implementation of sustainable practices, we complied this whitepaper, in which you could find out the 3 key steps for pharmaceuticals on the way to “sustainable packaging”.
The online event is with educational focus and will meet you with the end-to-end traceability technology in a real production. The course will provide all information about traceability system – from serialization to aggregation. It`s time to understand Track & Trace world!
Global pharma companies are looking to India. As per Pharmaceuticals Export Promotion Council of India (PHARMEXCIL) India’s pharmaceutical exports stood at US $16.4 billion in 2016-17 and are expected to grow by 30 per cent over the next three years to reach US$ 20 billion by 2020. India is the largest provider of generic drugs globally with the Indian generics accounting for 20 per cent of global exports in terms of volume.
The report collected publicly available recall information from the FDA and European regulators. The report then identified 59 instances where drugs were recalled due to glass-related issues between January 2014 and July 2021. The causes identified include recalls for delamination, particulate matter, breakage, ethylene oxide residuals and adhesive issues.
SAP Information Collaboration Hub for Life Sciences facilitates collaboration along the pharmaceutical supply chain. This is a productive business network for the pharmaceutical industry that facilitates messaging of traceability and serialization data across the supply chain, enabling each customer to connect once and only once to share data with all partners and regulatory bodies.
Today, there is no individual identification of primary glass containers for parenteral use. If a problem is identified during a process step, manufacturers are unable to define exactly which products may have been impacted. As a result, they adopt either an “over segregation” or “full batch write-off" policy. This can have significant financial impact from lost or missed revenue and lead to drug shortages in the market.
SIG claims it is not onlyhelping brands to engage with consumers but also integrate complete transparency into the whole value chain. IoT and smart packaging innovations are opening up new possibilities for both tracking and interaction, and SIG’s digital marketing solutions allow every product to act as a data-driven information and media source. SIG’s QR code closure solution was first launched in China in 2020.
Since the launch of the AR experience, the brand has had almost 2,500 session startups, with a progressive growth of almost 50% more sessions each month. “Consumers are engaging with the AR experience for 1:18 seconds per view, which is certainly at the higher end of engagement time across all mediums in which we reach our loyal buyers,” he says. “Additionally, we’ve had almost 20% of AR users come back to the experience and try it again, which allows us to both entertain our consumers and continue to share our brand message and promote brand transparency.”
“Connected packaging allows brands to be truly consumer-centric, with insights gleaned about product preferences, location and demographic information, as well as a direct-to consumer channel to provide product information,” explained Jenny Stanley, MD at Appetite Creative. “Through administration dashboards, it is possible to identify who redeemed which coupon, scanned which QR code, how long a user stayed on the platform, manage competitions and store data in an easy-to-access, real-time, GDPR-compliant platform,” she added.
Expressing its concern on the rising incidences of spurious and adulterated drugs in India, the Department related Parliamentary Standing Committee on Commerce has recommended to the government to roll out a track and trace mechanism at the earliest for the detection of authenticity and genuineness of medicines and medical devices from manufacturers to end users in supply chain.
In order to form an interconnected world, with a cost-effective healthcare supply chain, the adoption of common international standards becomes a crucial requirement for the success of all stakeholders. The fact that a country cannot operate in isolation, implementing domestic standards, is exemplified by the Chinese Track and Trace system implemented in December 2015. Serialisation and aggregation at all packaging stages, from a single unit up to a pallet, was an imperative requirement.
Grâce à l’appli Seek, notre journaliste a enfin pu mettre un nom sur les plantes et les animaux qui l’environnent. Un outil collaboratif capable d’identifier un être vivant à partir d’une simple photo, comme l’appli Shazam reconnait un morceau de musique.
Indian supply chain and related companies see that US FDA draft guidance on enhanced drug distribution regulations at the package level will add extra touch of security to the pharmaceutical exports into the US. The guidance, according to the US FDA, is intended to assist supply chain stakeholders, particularly trading partners, for enhanced drug distribution safety at the package level under section 582 of US FDA Act, effective from November 27, 2023. In fact, the guidance replaces the DSCSA (drug supply chain security act) to be phased out since 2013 to improve the oversight of trading partners.
Serialization offers both opportunities and challenges for companies in Life Sciences. The use of sGTIN and SSCC numbers is a sound method to battle counterfeit drugs and keep the supply chain for pharmaceuticals safe and free of corruption. But serialization – and the increasing pressure from regulators to become more transparent in your end-to-end supply chain – adds a growing complexity. In every aspect of your manufacturing, warehousing, and logistic processes. The good news? The stand-alone ATTP solution you are using for serialization can be integrated in your supply chain, more specifically in your existing or in a new (E)WM solution, optimizing your operation efficiency and simplifying your processes.
In today’s world of pharmaceutical serialization where we have dozens of different regulations and laws pertaining to pharmaceutical and medical device serialization across the globe, the Quality Person (QP), Quality Assurance (QA) or Quality Control (QC) team in the pharmaceutical industry has to put in a lot of efforts to validate the entire system and ensure that all the process, procedure, and method is working correctly and would consistently lead to the expected results.
The first response to the global pandemic for many manufacturers was to go digital in their operations as fast as possible. While going digital is the right path, it is not enough. The trends identified by Gartner can help manufacturing CIOs prepare for similar future disruptions in the long run and mitigate challenges such as lack of customer touchpoints, entering new markets or product lines and financial distress.
Track & Trace
