Shipping a consignment, no matter what is being shipped, always has an element of risk. If your shipment contains pharmaceutical goods, the risk is increased as pharma shipments are more prone to damage, theft, or tampering in transit and pharma track and trace systems are not helping either. The moment you hand your goods over to someone else, you lose control of the way it is handled from first mile through the last mile. Tracking your shipment using different technologies has come in handy over the years to curb the risk, but only to a level, and when you are dealing with pharma track and trace it becomes even trickier. Your pharma track and trace system needs to be built differently from your regular shipment tracking system.
But how? Let us dig into the main differences between pharma track and trace and pharma supply chain monitoring as well as how the latter makes a real difference.
With increasing complexities in the pharmaceutical world, there is also an unavoidable requirement of track and trace technology to stay on top of the pharma supply chain needs. Technology to keep up with the movement of these complexities, technology to keep a track of the pharma supply chain, and technology to ensure product safety in any situation, almost doing away with any associated risks. A technology that is easy to use and is aligned to deliver on your pharma track and trace needs.
Traditionally, tracking a shipment depended on communication with the various participants of the supply chain — the freight forwarder, the driver, the 3PL company. Technology has brought with it advantages like RFID tags, GPS tracking devices, and sensors which can track a shipment without having to rely on someone else. Let’s have a look at how pharmaceutical track and trace technologies help one stay on top of their shipments.
Pharma Track and Trace
To track your pharma shipment simply means to be in the know of where it is and a less than accurate ETA, which means pharma track and trace essentially only provides information with regards to:
- Location — where your shipments have reached and what the ETA is. It lacks detailed information like reasons for stoppage, reasons for delay, causes and duration of route deviations, etc.
- Condition — sometimes, tracking devices like data loggers can tell you the condition of the shipment after it arrives. But the condition data is only at a shipment-level and not at package-level. It basically lacks the level of granularity that is required for pharmaceutical goods.
Pharma Supply Chain Monitoring — What It Means and Why You Need It
Monitoring your pharma supply chain is so much more than just knowing the location and condition of the goods in the warehouse & in transit. Which means going beyond pharma track and trace to better technologies.
It gives you information that is actually useful for you to plan ahead or take timely actions that help your supply chain become leaner and less prone to risks — theft, spoilage, damage, and several others.
To be precise, having any kind of information makes sense only if you’re able to do something about it. In the same way, having data about your pharma shipment is only useful if you can take an action using that information, that too, in real-time. Having a pharma supply chain monitoring plan in place means you have data regarding every single detail in your supply chain right from the condition — temperature, humidity, shock, altitude, organic gases in some cases — to real-time location, which you can review, analyze, and archive into a secure portal.
The system that you use should be capable of storing data even when there’s no or limited connectivity and transmit it to cloud later when it’s back in connectivity. This would provide a verifiable audit trail, no matter where the goods are travelling.
Here is the level of detail that a good pharma supply chain monitoring system should provide you with:
What You Need |
Why Do You Need It? |
Package-level visibility across all modes of transport |
To know about stolen goods: Package-level visibility allows you to know and blacklist the products stolen. It also helps improve your chances of recovery because you know where each package is. To manage package-segregation: While shipping by air, your packages could be loaded in different flights to reduce downstream delays by airlines. In such a scenario, having package-level visibility is not just helpful, but necessary to keep a check on package-segregation. To manage multimodal shipments: Pharma uses multiple modes of transportation based on the type of product — generic drugs, patent drugs, clinical trials. Keeping track of the shipment during such frequent change of hands is only possible if you know where each of your packages is. To manage international movement: When pharmaceutical goods move internationally, there’s a lot more to handle than just the location — managing condition-sensitive goods with varied infrastructure, handling customs regulations in different countries (package severance, again), maintaining conditions throughout the journey including high-touch handling, risk of theft & counterfeit. |
Real-time location + condition |
For faster decision-making: To be able to decide the course of action when the condition is being impacted, rather than upon arrival. For prompt damage control: To be able to decide on sending another batch of an essential product in time, if it has gone through irreparable damage due to unavoidable condition change while still in transit. |
Unified visibility across chain of custody |
To collect end-to-end data: Data aggregation does not work in this case since patents and Intellectual Property Rights are different in various countries. Using comprehensive visibility, it becomes easier to flag instances where there has been a deviation from your preferred route, affecting your IPR or insurance cover. To help combat counterfeit drugs/theft: Having a complete visibility helps you work through the dedicated lanes of movement for different products, which is a chain of custody proof, right from the point of manufacturing until the point of consumption. To have clear lines of accountability: Having verifiable and unbroken visibility across the chain of custody helps identify responsibility for possible liability, and to keep every stakeholder (such as transporters or warehouse operators) compliant without relying on them for data. |
Demand signalling |
To keep a check on safety stock: Pharma usually holds a lot of safety stock, even as much as 4-5 times of a consumer goods company. With generic drugs and competition, to optimise costs, they are moving to JIT models. The more safety stock you hold, the more it eats into your working capital and margins. Through constant and unbroken flow of visibility, you get a good understanding of the demand and consumption pattern, knowing automatically how much stock is required, and how much needs to be dispatched to a particular area, reducing the level of safety stock needed. With constant visibility, you can also minimize transit time and ensure that the lower safety stock is a calculated risk, using historical transit time analytics. |
Pharma specific compliances |
To keep a check on 21 CFR Part 11 compliance:So that you are certain that the platform you are using is FDA CFR Part 11 compliant — that the electronic data is authentic, ensuring FDA compliance. To make sure that the sensor is NIST-certified: So that you can be sure that the sensors are calibrated and are indicating an accurate condition of your goods. |
The above assessment lays out how pharma supply chain monitoring is not only much better than just tracking your pharma shipments, but also improves your ROI and throughput, and contributes to the wellbeing of the end-consumer. Unlike a regular supply chain, where a temperature excursion could mean a spoiled batch of goods, in a pharma cold chain, a temperature affected batch could have dire consequences.
To avoid such situations, it is essential to strike a tradeoff between data sharing and data security. For this, your backend systems should be able to handle data securely. You need a system that enables faster decision-making, better risk mitigation, and improved operational efficiency. Such a system should go beyond pharma track and trace to provide you with the ability to enable integrated demand forecasting and production planning for better responsiveness to market/demand fluctuations.
What helps even more is having dedicated teams manning your monitoring system, and to be able to automate to a level where dependence on human intervention is negligible.
