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Serialization and Track & Trace: Ensuring Compliance in Pharmaceutical Manufacturing

In a recent inspection of pharmaceutical manufacturing units by the Central Drugs Standard Control Organization (CDSCO), Indian drug regulator, approximately 36% of the units faced closure due to non-compliance issues. This statistic underscores the critical need for stringent compliance measures within the pharmaceutical industry.

India, home to around 10,000 pharmaceutical manufacturing units, with the majority being micro-small and medium-scale facilities, is on a trajectory of remarkable growth. Currently valued at $55 billion, the Indian pharmaceutical sector is poised to reach $130 billion by 2030 and a staggering $450 billion by 2047. With exports contributing $27.85 billion, India is reinforcing its position as the ‘Pharmacy of the World.’

Serialization, a key process within the pharmaceutical supply chain, plays a pivotal role in enhancing transparency and safeguarding product authenticity.

What is Serialization in Pharmaceutical Packaging?

Serialization involves assigning a unique identifier to individual units or batches of pharmaceutical products at various packaging levels – primary, secondary, and tertiary.

The implementation of serialization enables the tracking and tracing of products throughout the supply chain, facilitating efficient recall procedures and reducing the risk of counterfeit medicines entering the market. This process involves establishing a parent-child relationship between individual units and their respective packaging levels, ensuring accurate identification and verification.

At Utopia Digitech, part of Holostik group, we specialize in providing advanced track and trace solutions that incorporate serialization and aggregation functionalities. Our solutions, spanning from L1 to L5, empower pharmaceutical companies to comply with regulatory requirements, enhance operational efficiency, and promote consumer safety.

The Three Levels of Packaging

Understanding the different levels of packaging in the pharmaceutical industry is crucial for ensuring product safety and compliance. Here’s a simple breakdown of each level:

Why Serialization Matters?

  1. Regulatory Compliance: Meeting global standards and avoiding shutdown risks
  2. Counterfeit Prevention: Creating an unbreakable chain of authenticity
  3. Supply Chain Visibility: Real-time tracking from manufacturer to patient
  4. Quality Assurance: Instant recall capabilities and product history tracking

To ensure effective product traceability, many countries adopt serialization guidelines established by the GS1 organization. By working closely with regulatory bodies, GS1 develops frameworks that utilize serialization to enhance product tracking.

Utopia Digitech: Your One-Stop Solution for GS1 Barcode Labels and Packaging

At Holostik, we understand the complexities of the pharmaceutical industry and offer globally recognized GS1 standards serialization and track & trace solutions to help you meet regulatory requirements and protect your brand reputation.

Our solutions cover the entire supply chain, from primary packaging (individual product units) to secondary packaging (product bundles) and tertiary packaging (shipping cartons).

By leveraging advanced technologies, we ensure seamless integration with your existing systems and provide real-time insights into your supply chain.

To implement serialization, you’ll need to incorporate the following key elements:

  1. Global Location Number (GLN): Identifies the country of origin.
  2. Global Trade Item Number (GTIN): Specifies the product type.
  3. Serial Number (SGTIN): A unique identifier for each individual product within a specific GTIN.
  4. Lot Number: Indicates the manufacturer-specific batch from a particular production run.
  5. Expiration Date: Specifies the product’s validity period.

By integrating these elements into your product packaging and supply chain processes, you can significantly improve product traceability, enhance quality control, and meet regulatory requirements.

Why Serialization is the Best Line of Defense Against Pharmaceutical Counterfeiting?

Serialization plays a crucial role in combating counterfeiting. It enables robust product traceability, allowing authorities and consumers to verify the authenticity of products throughout the supply chain.

Here’s how serialization works to deter counterfeiting:

  1. Unique Identification: Each product is assigned a unique serial number (SGTIN), making it distinct from others of the same type.
  2. Data Capture and Verification: As products move through the supply chain, their serial numbers are scanned and recorded at various checkpoints. This data is then transmitted to a centralized database.
  3. Real-time Tracking: The database allows real-time tracking of product movements, identifying any deviations from the authorized supply chain.
  4. Anomaly Detection: Automated systems can detect anomalies, such as products appearing in unauthorized locations or with discrepancies in their serial numbers.
  5. Authentication and Verification: Consumers can use mobile apps or other tools to scan product codes and verify their authenticity against the centralized database.

By implementing serialization, regulatory authorities, manufacturers, and consumers can work together to:

  • Disrupt Counterfeit Networks: Identify and dismantle counterfeit operations by tracking the movement of illegitimate products.
  • Protect Public Health: Ensure that consumers receive genuine, safe, and effective products.
  • Safeguard Brand Reputation: Protect brand integrity and consumer trust.

In essence, serialization provides a powerful tool to combat counterfeiting and safeguard the integrity of supply chains.

Are you ready to transform your pharmaceutical supply chain? Discover how Utopia can be your trusted partner in compliance.

Reach us at 📞 0120-4192700 and ✉ info@utopiadigitech.com or visit 🌐 www.utopiadigitech.com

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Increase your ROI with Utopia Digitech track and trace solutions

Various business organizations in the current times are constantly focusing on identifying ways to improve their supply chain management system. They employ all possible means in this direction. Track and trace solutions are among them because every business nowadays requires real-time tracking of their goods and shipments for better supply chain management.

This is the reason why we at Utopia provide our clients with end-to-end and comprehensive GS1 track and trace solutions for expanding the efficiency of their supply chain management.

Why Choose our Extensive Track and Trace Solutions

Regardless of where your business stands, the global marketplace has been pretty turbulent lately. That is not all; the standard methods in a supply chain have grown much more challenging globally. Still, there is an extensive assortment of regulations that an organization must comply with when operating globally.

This is the reason why your supply chain management demands to be extremely flexible and capable of adapting to evolving global requirements promptly.

At Utopia, we understand all these concerns, and hence we have built excellent track and trace solutions that are perfect for catering to the supply chain management needs of all business sectors. By using our end-to-end-track and trace solutions, you can easily reduce product duplications and generate a higher return on your investments and a competitive edge in the market.

Mentioned below are a few more reasons why you must go for our track and trace solutions for your supply chain management.

Reduces the chance of product duplication

One of the most significant problems that business enterprises face during their supply chain management is overcoming the difficulty of product duplication.

By choosing out track and trace solutions, you can easily track your products for any duplication and identify and fix problems early to reduce the duplication possibilities and save your valuable time for other operations.

Increase efficiency

With our comprehensive track and trace solutions in place, you can increase your functional and operational efficiency by an automatic and immediate update in your books of accounts, leading to zero human errors and delayed supplies and vendor payments.

Apart from this, fewer reconciliation requirements enhance the speed of transactions and diminish the expenses for the organizations.

Better Inventory management

The most significant reason to invest in our business is that we understand how the mismanagement of inventories can lead to substantial losses for your business.

This is the reason why we have developed extensive and far-reaching track and trace solutions that allow you to manage your inventory in a better way. In addition to this, our track and trace solutions can further enhance on-time delivery by regulating all activities across your supply chain and point towards more efficient demand planning.

Reduce operation time

Lack of automated track and trace solutions can take up a lot of your valuable business time in manual tracking and paperwork, which is additionally more prone to human errors. By choosing our automated track and trace solutions, you can reduce your operations time greatly.

You can foster better interaction and collaboration between suppliers, partners, and distributors. After looking at the points mentioned above, you can infer that you can have a more centralized view of your supply chain with the right track and trace solutions.

Utopia is a market leader in presenting high-grade track and trace solutions tailored to your distinct industry needs. Our impeccable assistance and bug-free software solutions always ensure high-level profit and productivity.

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3 ways warranty management can improve your business

Every year, organisations lose a large amount of money due to warranty claims processing issues. So, there is a dire need for effective warranty management that can reduce warranty spending, improve the quality of products, increase supplier recovery, and enhance end-customer satisfaction. In today’s blog, we discuss three ways automated warranty management systems can improve your business.

Faster claims process

An automated warranty management system in place helps to easily track warranties across the merchandise lifecycle. The system also helps in optimizing product value. The process helps in making the warranty claims process faster. It saves you an ample amount of time in warranty claim evaluation which otherwise is wasted in dealing with heaps of documents in case of a manual warranty management process.

Improved client satisfaction

Implementation of warranty management system improves client satisfaction manifold. The system holds an integrated data framework which ensures swifter data recall for customers and other stakeholders. The system helps in boosting brand image of the company by providing services on time.

No fraud claims and low operational cost

Warranty processes and policies are important part of a business enterprise. An automated warranty management system in place helps to make the data more transparent. This reduces the chances of false claims and thus helps in improving the warranty management of the organisation. Moreover, warranty management also improves product quality considerations, customer and manufacturer relationship and operational efficiency. This together brings down the costs of the organisation.

Utopia provides an effective warranty management process through which one can track all warranties throughout the lifecycle of the product. The process not only ensures improved customer satisfaction but increases product quality and reduces service costs. We provide customised warranty management system through smart labels or holograms incorporated with QR codes.

When the consumer scans the QR code all the product information like manufacturing date, expiry date, warranty period, etc. feeds into the database of the manufacturer. This information later helps the manufacturer, retailer, and the consumer in processing warranty claims with ease.

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Top 3 reasons you need inventory management system for your business

Are you planning to start a new venture? If you’ve set your foot in the world of business, and still don’t have any idea about managing the flow of goods in your system; well, this article has got you covered!

What is Inventory Management?

Inventory management is defined as having the right products at the right place & time. As simple as it may sound, without proper planning and organization, you are not very far from falling into a soup of problems that will hinder the process of your hard-earned business.

It’s a chain where each one in the pyramid right from the sourcing department to the retailers has equal roles to play.

Manufacturing companies, marketing, and sales, all prefer more inventory. Deciphering problems in warehouse management by increasing the storage area and possessing knowledge about the number of warehouses in a particular area will also demand more inventory.

Let’s see this with a simple example.

A customer comes to a retail shop to buy a particular item. It isn’t available there, so the manager sends an employee to the warehouse to check. If there’s still no stock there, they need to contact the manufacturing unit that has to eventually contact the sourcing department for the supply of raw materials.

Due to mismanagement of the retailer, there’s a line of problems created which could be easily solved if the retailer had invested time and money in a reliable inventory management solution.

3 Main Reasons You Need Inventory Management

Saves time

Having a clear knowledge of the number of supplies at a given moment cuts off unnecessary running of employees here and there to check the warehouses. Instead, they can invest this time in some other fruitful tasks.

Saves money

Buying bulk of goods that have good demand is beneficial as it cuts down the overall cost to the company. Moreover, there’s no obstruction of cash flow from the customer.

Customer satisfaction

Market trends are ever-changing and if you can provide what the customer wants, not only do you retain a customer but also satisfy their need. There are various methods you can put into practice. Preparing spreadsheets, ABC analysis, bulk shipment, demand forecasting, drop shipping, and six sigma to name a few.

Do you think this is too much to handle?

If you want someone you can trust for warehouse management solutions, Utopia has your back.

We are among few companies with CMMI Level 3 certification and have a team of in-house software developers who can cater custom warehouse management solutions for your business. Right from the stock count, stock supply, and customer satisfaction, you’ll get everything here!