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In many industries, manufacturers are responsible for developing products that align with various safety standards outlined by government agencies and regulatory bodies. For example, US-based manufacturers of pharmaceuticals, medical devices, and food and beverage products all must adhere to the many ISO requirements and Good Manufacturing Practices outlined by the Food and Drug Administration. Failure to do so can result in a number of health and safety concerns, a damaged reputation, and punitive actions from regulatory agencies.
In order to avoid the many challenges that arise from quality issues, manufacturers must ensure that they have complete visibility and control of their supply chain and manufacturing facilities. In order to maintain this level of control, businesses have to focus on their track and trace capabilities.
An overview of track and trace systems
Track and trace systems are solutions used by manufacturers to manage the raw materials and components as they progress through supply chains and ultimately through the manufacturing process, distribution, and into the hands of consumers.
Not only does a track and trace system help reduce quality defects, but it also allows manufacturing companies to fulfill compliance requirements.
Historically, manufacturers have relied on more cumbersome, paper-based track and trace systems to manage quality and compliance. However, with the advent of the fourth industrial revolution (Industry 4.0) alongside the Industrial Internet of Things (IIoT), manufacturers are taking advantage of a completely integrated track and trace software to manage product flows throughout their facilities.
Below, we get into track and trace for two key industries—food and pharmaceutical manufacturing.
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Track and trace for pharma manufacturing
When it comes to the pharmaceutical industry, a tracking and tracing system is a critical component for operation, given the particular importance of the products. In addition, regulatory bodies like the Food and Drug Administration (FDA) provide strict guidelines that pharma companies must adhere to.
The process of manufacturing medicines and medical equipment requires several different raw materials and parts. Regulatory bodies need manufacturers to label, track, and document each item along the supply chain and life of the product.
The first step to traceability for pharma manufacturing is serialization. This involves finding unique identifiers to append to the different items under production. Manufacturers can then track the item in real-time during and after the production process. In addition, the pharma company should be able to authenticate the unique identifier at any time in the product’s lifetime.
In some jurisdictions, regulators require more than serialization. So, in addition to the unique identifiers, regulatory bodies also need manufacturers to add more detailed data. The FDA, for example, outlines the many different regulatory criteria in their list of Current Good Manufacturing Practices (CGMP).
Track and trace for food manufacturers
Tracking and tracing food items requires manufacturers to account for things like product sources, ingredients across the supply chain, and the environments that the food is processed in.
Furthermore, food companies also have to track and trace their products after shipping. In other words, they need to keep tabs on each product even when it’s on shelves in the supermarket. In cases like food-borne disease outbreaks, manufacturers and government agencies must easily be able to track food products to assess the source of contamination and recall contaminated products.
In 2020, the FDA admitted that its tracking and traceability requirements didn’t extend to farms and restaurants, excluding a significant part of the food supply chain. The agency has since worked to improve traceability with guidelines outlined in the Blueprint for the New Era of Smarter Food Safety. This blueprint embraces the use of more advanced trace and track software and aims to improve traceability through predictive analytics.
The importance of track and trace software
Track and trace software goes further than manual record-keeping in paper files or basic spreadsheet tools. Instead, more digital approaches to traceability like barcode and QR scans provide a more manageable way to track and trace food and pharmaceuticals.
In addition, modern track and trace software provides real-time insight into the production process, allowing food and pharma manufacturers to identify bottlenecks. Relatedly, companies identify areas where potential quality degradation might occur, enabling them to take appropriate corrective action.
Also, the pharma and food industries usually deal in various products or raw materials simultaneously. Modern track and trace systems are well-equipped to adequately handle multiple materials at the same time, making it easier for manufacturers to keep tabs on a variety of products.
These systems are also configurable, allowing manufacturers to tweak them to dovetail with their specific food or pharma production operations. Furthermore, track and trace software fosters continuous improvement by leveraging analytics to comb through historical tracking data.
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Learn how manufacturers in regulated industries are simplifying safety and compliance practices with Tulip's platform.