Pharmaceutical Supply Chain Traceability
Collecting and contextualizing data from “Lab to Jab“ will improve yield, throughput, safety and compliance
Frequently Asked Questions On Pharmaceutical Supply Chain Traceability
The pandemic has brought an entirely new level of visibility on the challenges and realities of bringing new prescription drugs, pharmaceuticals, and medications through FDA approval to market. Consumers are increasingly thinking about the broader repercussions of their lifestyles and are asking harder questions about where their prescriptions are coming from and how was the drugs quality control managed as well as tracking and tracing of the various changing logistics of origin after departing the pharmaceutical manufacturer. Here are a few of the frequently asked questions you should consider if you are responsible for pharmaceutical manufacturing.
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What is Pharmaceutical Manufacturing?
The pharmaceutical industry is critical to human survival. Without medicine, many of the miracles of modern healthcare would not exist. It would follow that the most technically advanced manufacturing processes in the world drive pharma, right? Not necessarily. While the most advanced smart manufacturing technologies, often referred to as Industry 4.0, have been utilized in food & beverage, mining and metals, and more, it has yet to find widespread adoption in pharmaceutical factories.
The process behind Pharmaceutical Manufacturing.
Extensive raw material traceability plays a major role in smart manufacturing, particularly in the face of the strict regulation of pharmaceuticals. Being able to access data on incoming ingredients, their movement, storage, manufacturing processes, personnel assignments, and more provides critical details beyond whether a batch simply went bad. Now we can trace back problems to specific equipment and use diagnostic information to determine if there was a failure on that machine or with its operator.
4 critical issues facing the pharma and healthcare industries
With the rising need for personalized drugs, smart manufacturing makes it possible for pharmaceutical factories to move away from batch manufacturing in which production is stopped for quality assurance testing. Each time production is stopped, lead times increase, and something can go wrong. With the flexibility, precision, and speed new technologies afford us, continuous manufacturing becomes possible by facing these 4 issues:
- With continuous manufacturing, substances move nonstop at a single facility, eliminating hold times, reducing the probability of human error and the likelihood of drug shortages.
- A more connected factory can better tap into emerging markets, compete with generics, and optimize its products.
- Greater visibility leads to globalization that can still align on a local level.
- Production times can be slashed with access to real-time information.
Why is traceability important in the supply chain and specifically for pharmaceutical safety?
Pharmaceuticals are closely and extensively regulated, of course. So much so, it can be difficult to adopt new technologies. Such change, after all, would likely lead to process revalidation, an undesirable initial result. Plants use specific kinds of equipment that require meticulous inspection, their processes validated in scrupulous detail. Despite the hurdles, smart manufacturing offers incredible upside in terms of supply chain traceability. Upside that is well worth it.
Prior generations of breakthroughs in manufacturing were centered more on the shift from mechanical technology to digital computing and communications. This current shift takes those advances a step further by adding autonomy through artificial intelligence (AI), machine learning (ML), and the internet of things (IoT). In other words, we’re now endeavoring not just to produce massive amounts of data but to digest it into smart decision-making. These autonomous systems seek to improve manufacturing processes and quality assurance to increase productivity, efficiency, and quality while reducing risk and adhering to strict regulations.
What are recent renovations in pharmaceutical supply chain safety?
With ThinkIQ’s Transformational Intelligence platform, pharmaceutical manufacturers gain access to a complete overview of all operations. From lab to jab, our smart manufacturing technology, including our semantic model and material ledger, dramatically reduces recalls, identifies weaknesses in the plant, and eliminates safety concerns.
A material ledger provides a novel approach to intelligent tracking of material and energy movement and transformations, their associate monetary value, and quality data. It delivers insight that improves yield, quality, safety, compliance, and brand confidence through a fact-based granular, data-centric contextualized view of material flows and related provenance attribute data. We utilize existing IoT infrastructure on which a cyber-physical system can be built to decentralize decision-making in favor of autonomous task-completion of all but the highest-level exceptions. It’s the next generation of smart manufacturing for the most mission-critical industry.
How is pharmaceutical manufacturing technology affecting the Healthcare and Medical Industries?
The FDA has approved continuous process manufacturing since 2015, including for products made by Janssen, Eli Lilly, and Pfizer. The FDA has cited many positive advantages of continuous processing:
- The elimination of manual handling and human error
- Increased quality assurance through online monitoring and control
- Reduced manufacturing time and increased efficiency
- Reduced capital costs utilizing smaller equipment and less manufacturing space
- More nimble responsiveness in the event of a drug shortage
- More tailored drug production to fit the needs of precision medicine
Manufacturers also enjoy greater utilization, more flexible batch sizes, simplified scaling, more control over critical process parameters, less energy consumption, and more reliable scheduling.
Why Artificial intelligence is helping pharma manufacturers define and pursue next level security and developments in the global regulatory environment.
In pharmaceutical manufacturing, patience is no longer a virtue. With the rise of personalized medicine and swift changes in consumer demand, batch processing is becoming less viable. Considering increased competition, rising costs, and pricing pressure, product revenues have declined to the point that the same technologies the industry has relied on for decades are finally showing their limitations. The use of artificial intelligence is facilitating new levels of visibility and understanding of ingredients as they flow across the supply chain.
What is the Roadmap to Becoming a Smart Manufacturing Firm?
ThinkIQ’s Transformational Intelligence platform, can provide your pharmaceutical operation a complete overview of all manufacturing processes. Our in-depth, industry-specific experience with supply chain and manufacturing concerns help manufacturers avoid recalls from temperature spikes and assembly-line slow down, and spot weaknesses in product that could become a major safety concern. By identifying and executing even a small change in raw ingredients or suppliers can significantly increase your bottom line. We use industry benchmarking and KPIs to surface the manufacturing issues that matter across plants, across supply chains, and around the world.