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By connecting to the Elemica Digital Supply Network, enterprises manage supply chain execution and quality across all of their trading partners, hospitals, and pharmacies, while gaining visibility and insights to the needs of their customers and patients. All networked multi-enterprises can track and manage quality, orders, inventory, and shipments in real time as products flow through from raw material supplier all the way to the patient.
SUPPLY CHAIN CHALLENGES
A lack of visibility into the supply chain may be the root of many challenges faced by the pharmaceutical industry. Drug shortages. Counterfeits. Many of the hard-hitting headlines critiquing the industry today highlight how patients, regulators and retailers alike do not often know where drugs are coming from and how they were made.
But for the industry, the path to visibility represents more than an ability to track-and-trace goods for the consumers’ sake. In some cases, it may also boost margins and result in a safer product. Being able to see where supply chain problems lie opens the door to addressing them.
The supply chains for designing, manufacturing and distributing pharmaceuticals and medical devices plus those providing healthcare services will integrate so that all partners can see the full picture and help them plan ahead more accurately and cost-effective. Collaboration between the parties involved in the healthcare provision will contribute to make the industry more efficient. Differences in process permeate the industry, making any change in standards or control difficult to implement.
Often, supply chain issues come down to differences in processes or systems. A single drug or treatment may be administered to hundreds of hospitals through distributors, but with more than 5,000 such healthcare facilities in the U.S. alone, it can be tough to keep track of and meet each buyer’s requirements.
Quality and Compliance
Roughly 80% of active pharmaceutical ingredients and 40% of finished drug product are imported into the U.S. from overseas. Manufacturers in India and China, in particular, are a key source of the generic drugs prescribed to Americans in ever-increasing volumes. In the U.S., the Food and Drug Administration is tasked with ensuring facilities based in foreign countries remain in compliance with Good Manufacturing Practices, a standard for quality production of pharmaceuticals.
Recently, inspectors from the FDA have issued warning letters to manufacturers abroad at an increasing rate, putting quality and compliance in focus as the pharmaceutical industries in China and India look to move up the value chain into novel drug development.
It’s not just manufacturing, though. Shippers and distributors will soon have to comply with regulations under the Drug Supply Chain Security Act, which requires any company wishing to sell pharmaceuticals in the U.S. to facilitate product “traceability” by 2023.
While all medicines are sensitive to the rigors of cross-border shipping, biologics in particular are heat sensitive and susceptible to contamination. Keeping these drugs cold is a crucial part of the supply chains that connect drug makers to patients.
Cold-chain shipping will take on an even greater role as more and more cell and gene therapies progress through clinical testing and onto markets worldwide. Additionally, as certain therapies are by definition personalized to each patient, cold-chain technology needs to be integrated with tracking software capable of maintaining detailed chain of identity and chain of custody.
Supply chain visibility, operating at its full potential, gives you the power and knowledge to manage, control, and review orders and shipments across the entire supply chain including those that rely on third-parties. As such, its value to improving your business profitability, mitigating risk, expanding the brand loyalty and reputation, and productivity should not be underestimated.
Pharmaceutical companies obtain highly-capable order tracking with real-time notifications, with Elemica SEE solutions. The solution assists your understanding into where holdups tend to occur and can be corrected.
With more regulations being handed down by other international agencies (IPEC – International Pharmaceutical Excipients Council) and standards bodies (ICH Q7, ICH Q10, etc.), with emphasis on outsourcing and suppliers, document retention down the supply chain tiers, and clarifications from ISO 9001:2008 concerning the control of outsourced processes, companies need to sit up and pay attention to their supplier quality programs. Elemica QUALITY provides a sharper focus on supply chain issues with full depth for e-pedigree and anti-counterfeit measures.
Elemica QUALITY places the proper emphasis on the control of suppliers as outsourcing activities increase. Poor cost of quality resulting in rework, waste, delays in product approval, resource inefficiencies, corrections and removals, enforcement actions, which impacts the bottom line can be all managed and improved. With real-time data that demonstrate control over suppliers – metrics, data analysis, and action items Elemica QUALITY provides better control over the supplier base with increased collaboration, resulting in standardized practices and processes and improved transparency and auditability.
Elemica BUY connects, automates and makes visible supplier management processes across the multi-enterprise procure-to-pay process. This ensures compliance, oversight, and strong supplier relationships are managed between suppliers, contract manufacturers, and inbound shipments. Although typically raw materials and services may be low in cost compared to the prices of the pharmaceuticals that are produced from them, the risks to supply chains can have devastating quality and financial consequences.
Elemica MOVE connects and automates the silos, fragmented, or otherwise uncoordinated communications and executions between differing participants and systems of a supply chain. Improving this coordination removes major losses due to excess of some products and a lack of others. Elemica MOVE provides execution and insights impacting timeliness of deliveries, distribution costs, sales, customer satisfaction, and more. Not only are medications affected — even products like blood vials with additives that have short shelf lives may be saved as they now reach their destination in time.
Products go bad due in the pharmaceutical industry due to temperature control failure. Using Internet of Things (IoT) and other sensor devices connected to the Elemica Platform through APIs in real-time, widespread issues of this problem can be removed. Considering that 30 percent of discarded pharmaceuticals are wasted purely because of temperature-related logistical problems. Plus, 25 percent of vaccines arrive degraded because of incorrect shipping. Finally, 20 percent of all temperature-sensitive products suffer some damage during shipping.
Elemica PLATFORM collects data in real-time from the sensors or at specific intervals. Event monitoring and event management triggers are set as temperatures in transit varies for correction purposes. The data is also able to be integrated with Elemica Quality to manages Total Quality Management and conformance reporting need for the products in transit. As products move out of the acceptable ranges, non-conformance reports and and events are triggered for Corrective Action (CAPA).
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