Serialization is a key technology in modern data management and communication, particularly in industries requiring high levels of traceability and security, such as the pharmaceutical, food, and agrochemical industries, etc.

Understanding the right way to approach serialization is vital for businesses looking to ensure compliance, enhance security, and improve supply chain visibility.

We have written this article to provide you with information on understanding the fundamentals of serialization, starting points, best practices, and common pitfalls to avoid.

What is Serialization?

At its core, the serialization feature is a unique code-generation algorithm that can be assigned to individual sellable items.

This feature allows for easy integration and installation on packaging lines and offers unique control for printing and checking.

This process is important for creating unique identifiers for individual items, enabling tracking from production through to the end-user, ensuring authenticity, and combating counterfeiting.

Starting Points for Implementing Serialization

Implementing serialization effectively begins with understanding the specific needs of your industry and the regulatory requirements it must comply with.

For industries like pharmaceutical and food, where tracking and tracing products are essential for compliance and security, starting with a robust system designed for easy integration is key.

The initial steps involve:

1. Choosing the Right Serialization Solution: Look for solutions that offer unique code generation algorithms capable of assigning distinct identifiers to each sellable item. This specificity is crucial for ensuring that each product can be individually tracked through its supply chain journey.
2. Integration with Existing Systems: Opt for serialization solutions that promise easy integration with your current packaging lines. This minimizes disruption to your operations and ensures a smoother implementation process.
3. Scalability and Flexibility: Ensure that the solution you choose can scale with your business and adapt to future changes in regulations or product lines.

Best Practices in Serialization

When implementing serialization, several best practices can ensure success:

1. Unique Control for Printing and Checking: Advanced serialization solutions, like those offered by Jekson Vision, provide unique control over the printing and checking of serialized codes. This ensures high accuracy in code assignment and minimizes the risk of duplication or errors.
2.  Comprehensive Training: Training your staff on the new system is important for ensuring that they understand how to operate it effectively and recognize the importance of maintaining serialization integrity.
3. Regular Testing and Audits: Regularly testing the serialization system and conducting audits can help identify potential issues before they become significant problems, ensuring the system remains reliable and compliant.

Common Pitfalls to Avoid

While serialization offers numerous benefits, there are common pitfalls that businesses should be aware of:

1. Overlooking Regulatory Requirements: Failing to fully understand or comply with industry-specific regulatory requirements can lead to significant legal and financial repercussions.
2. Underestimating the Importance of Data Security: Serialization involves handling sensitive data. It’s essential to ensure that your serialization solution includes robust security measures to protect this data from unauthorized access or breaches.
3. Neglecting System Maintenance: Like any technology, serialization systems require regular maintenance to function optimally. Neglecting this can lead to system failures and operational disruptions.

Conclusion: Enhancing Security and Compliance with Jekson Vision

For businesses in the pharmaceutical, agrochemical industries, FMCG, and beyond, embracing serialization is about securing the supply chain, enhancing product integrity, and building trust with consumers.

Jekson Vision’s serialization, aggregation, and track and trace solutions stand out for their ease of integration, unique control over printing and checking, and their proprietary code generation algorithm.

As you consider implementing or upgrading your serialization system, remember the importance of starting with a clear understanding of your needs, following best practices, and avoiding common pitfalls.

With the right approach and technology, serialization can be a powerful tool in your business’s arsenal for security and compliance.

Discover how our unique code generation algorithm and easy-to-integrate systems can transform your product tracking and tracing capabilities. Visit Jekson Vision today to learn more and take the first step toward a more secure and compliant future.

The countries of Central Asia – Russia, Kazakhstan, and Uzbekistan – stand at the crossroads of stringent regulations and evolving technology.

The emergence of track and trace systems aimed at ensuring product authenticity and safeguarding public health has become important in these nations.

Here, we share the complex web of regulations governing serialization and traceability in Russia, Kazakhstan, and Uzbekistan, shedding light on how businesses must navigate to thrive in these markets.

The Imperative of Track & Trace: Beyond Compliance

Track & Trace systems have transcended their initial purpose of regulatory compliance. Today, they stand as pillars of transparency, efficiency, and consumer safety.

By enabling the precise monitoring of products throughout the supply chain, these systems not only satisfy legal requirements but also consumer trust and operational excellence.

Russia: Chestny ZNAK and the Fight Against Counterfeits

At the heart of Russia’s track and trace system is Chestny ZNAK, meaning ‘honest badge,’ a centralized platform designed to combat counterfeit drugs.

Enacted in December 2017, this legislation mandates the serialization of various products, including pharmaceuticals, tobacco, and alcohol.

The system employs a 44-character crypto code, providing cryptographic protection through open key encryption algorithms.

The primary objectives are to streamline quality control, prevent counterfeit products from entering the market, and monitor demand and supply dynamics.

Russia’s phased implementation, initiated in 2019 and set to culminate by 2024, demands compliance from every distributor and manufacturer in the pharmaceutical supply chain.

The consequences of non-compliance are severe, including substantial fines and product seizures.

In this landscape, understanding the intricacies of Chestny ZNAK is imperative for every industry player, from manufacturers to distributors.

The law’s phased implementation commenced in 2019, with varying serialization deadlines across industries. Notable deadlines include:

Key Dates to Take Note of:

• By November 1, 2023, importers are mandated to aggregate their goods and transmit the aggregation data to the Chestny ZNAK system.
• By March 1, 2024, stakeholders are obligated to submit returns of their products to the system and remove suspicious items from circulation.
• Starting January 1, 2021, non-serialized light industry products will face a ban.

The government has implemented fines and penalties for those failing to meet these requirements.

Kazakhstan: IS MPT and the Battle Against Counterfeit Drugs

Kazakhstan, like its neighboring countries, faces the challenge of combating counterfeit drugs. The IS MPT traceability system, set to be fully operational by 2025, mandates the serialization of pharmaceutical products.

The timelines are stringent: until July 1, 2024, 100% of drugs must be labeled, and by July 1, 2025, serialization must cover both prescription and non-prescription medications.

The serialization process involves a 14-digit product code (GTIN), a 13-character randomized serial number, a 4-character verification key, and a 44-character verification code.

These codes are not merely regulatory requirements; they are lifelines ensuring the transparent movement of medicines through the supply chain.

By implementing serialization, Kazakhstan aims to create a transparent supply chain, prevent drug shortages, and eliminate counterfeit drugs from circulation.

Key Dates to Take Note of:

As per the most recent information, the schedule for the implementation of serialization and aggregation is outlined as follows:

• Until July 1, 2024 – Mandatory labeling of 100% of drugs.
•  From July 1, 2024 – Serialization of drugs purchased by a single distributor (for government procurement – approximately 40%).
• From January 1, 2025 – Prescription drugs (about 30%) must be traceable and labeled.
• From July 1, 2025 – Serialization of non-prescription drugs (about 30%).

These timelines are crucial milestones, indicating specific percentages and categories of drugs that need to comply within each stage.

Uzbekistan: Embracing Transparency and Accountability

Uzbekistan, with its 36 million inhabitants, has embarked on a similar journey. The serialization program, part of the government initiative to combat counterfeit and illegal medicines, has reached its final phase in 2023.

For businesses operating within Uzbekistan, compliance is not just about adhering to regulations about embracing transparency and accountability.

For companies with complex information systems, integrating solutions with specific add-ons has become imperative.

Uzbekistan’s commitment to serialization reflects a broader global trend – one where technology and regulation converge to ensure the authenticity and safety of pharmaceutical products.

Key Dates to Take Note of:

Deadlines to keep in mind for Uzbekistan Pharmaceutical Traceability System are as follows:

•  September 1, 2022: Initiation of digital marking for medicines distributed in Uzbekistan
• November 1, 2022: Inclusion of products with primary packaging and medical and agricultural products
• January 1, 2023: Implementation of traceability for labeled medicines and expansion to cover 60% of medicines
• April 1, 2023: Extension of traceability to encompass 80% of medicines produced and imported into the country

Additionally, the government announced a track-and-trace pilot project that was scheduled to run from January 2023 to June 2023.

Jekson Vision: Your Trusted Partner in Serialization Solutions

In the face of Track and trace regulations in Russia, Kazakhstan, and Uzbekistan, Jekson Vision emerges as the thread that binds compliance, efficiency, and innovation.

Our legacy of providing cutting-edge Track and trace solutions transforms mere regulatory requirements into strategic advantages.

With advanced serialization technologies, real-time tracking, seamless integration, and robust data analytics capabilities, our systems not only ensure compliance but give your products a competitive edge.

Beyond technology, we offer comprehensive training and support, empowering your teams to navigate these complex landscapes effectively.

Our state-of-the-art serialization solutions not only ensure compliance with the requirements of Chestny ZNAK, IS MPT, and other global track and trace standards but also elevate your operations to unprecedented levels of efficiency and transparency.

By choosing Jekson Vision, you are not merely investing in a solution; you are investing in peace of mind.

Our tailored serialization systems not only meet regulatory demands but also empower your business with actionable insights, real-time monitoring, and robust data analytics.

As Central Asia propels itself into an era defined by transparent supply chains and safe pharmaceuticals, Jekson Vision is your trusted partner, helping you craft a future where every product is traced, every transaction is transparent, and every consumer is assured of the authenticity of the medicines they consume.

Embrace the future of serialization with Jekson Vision – where innovation meets compliance and trust meets technology.

For more details, reach us at marketing@jeksonvision.com or WhatsApp us on +91 9328233954

In today’s competitive and rapidly changing manufacturing landscape, ensuring product traceability is no longer just a good practice but a critical requirement.

Consumers are increasingly demanding transparency and accountability from the brands they choose, and regulatory bodies are implementing more stringent compliance measures.

This is where Track & Trace solutions come into play, offering a powerful combination of serialization and aggregation to achieve complete product visibility throughout the supply chain.

One of the key elements of Track & Trace is serialization, which involves assigning a unique identifier (UID) to each individual unit of a product.

This UID serves as a digital fingerprint, enabling manufacturers to track and trace the product’s journey from raw material to end consumer.

This level of detail is invaluable for:

• Reduced Counterfeits in circulation: Protecting brand reputation and ensuring product authenticity
• Enhanced Regulatory Compliance: Meeting stringent industry regulations and audits
• Enhanced Quality Control: Identifying and isolating potential issues quickly and efficiently
• Improved Inventory Management: Optimizing production planning and minimizing wastage

However, implementing a successful serialization strategy requires the right tools. This is where serialization software comes in, playing a crucial role in automating the process of assigning UIDs, managing data, and ensuring accurate and consistent tracking.

Choosing the Right Serialization Software

Here are some key factors to consider when selecting the right serialization software for your manufacturing organization:

1. Compliance Requirements:

• Ensure the software complies with relevant industry standards and regulations, such as GS1 and FDA 21 CFR Part 11.
• Choose software that can generate, store, and manage UID data in a secure and auditable manner.

 2. Functionality and Scalability:

• Evaluate the software’s ability to handle your specific production volume and unit types.
• Look for a solution that offers flexibility and scalability to accommodate future expansion.
• Consider the ability to integrate with existing systems, real-time data visibility, and
  reporting capabilities.

3. Indigenous Development of the software:

• Choose a vendor that has its own software development team.
• Has own dedicated facility/infrastructure to address ever-changing requirements promptly.

4. User Experience and Ease of Use:

• Opt for software with an intuitive interface and user-friendly design to facilitate adoption by your team.
• Ensure the software provides comprehensive training and support materials.

5. Integration with Existing Systems:

• Choose software that integrates seamlessly with your existing ERP, MES, and other production systems.
• This ensures data consistency and avoids manual data entry, streamlining the overall process.

6. Cost and Vendor Support:

•  Compare the pricing models of different solutions and consider factors like implementation costs, ongoing maintenance fees, and support options. Some solutions might look economical to begin with but would turn out to be costly in the long run.
•  Choose a vendor with a proven track record in the industry and reliable customer support.

7. Future-Proofing Your Investment:

• Invest in software that can evolve with changing industry standards and technological advancements.
• Look for solutions that are constantly updated and offer ongoing development and innovation.

Jekson Vision’s REESOURCE as Your Serialization Solution:

Jekson Vision’s REESOURCE offers a comprehensive serialization solution designed specifically for the needs of fast-paced manufacturing organizations.

REESOURCE addresses all the factors mentioned above, ensuring a seamless and efficient implementation of your Track & Trace strategy.

Benefits of REESOURCE:

• Compliance-driven: Complies with GS1 standards, FDA 21 CFR Part 11, and other regulatory requirements.
• Robust backend Infrastructure: REESOURCE is developed indigenously by Jekson at a dedicated facility in India, which hosts a development team of more than 150 developers. This ensures a lot of flexibility for our customers for custom development and ad-hoc integrations.
• Comprehensive functionality: Handles serialization, aggregation, data management, reporting, and more. It provides master data synchronization with ERP/SAP.
• Compatibility: Compatible with all major data exchange mechanisms (soap/rest/sftp/as2)
• Scalable and adaptable: Caters to diverse production volumes and accommodates future growth.
• User-friendly interface: Simple workflow and intuitive design for easy adoption and training. It has a customizable configuration.
• Integrations: Seamless integration with existing ERP, MES, and other systems.
• Cost-effective: Competitive pricing and flexible licensing options.
• Reliable support: 24X7 remote customer support team for comprehensive assistance.
• Future-proof: Ongoing development and updates to stay ahead of industry trends.

By investing in reliable and feature-rich serialization software like REESOURCE, you can achieve complete product traceability, improve quality control, boost operational efficiency, and ensure compliance with regulations.

This, in turn, leads to enhanced customer satisfaction, brand reputation, and market competitiveness.

Ready to take control of your product traceability? Contact us today to learn more about REESOURCE and discover how it can help you achieve your manufacturing goals.

Write to us at marketing@jeksonvision.com or WhatsApp us at +91 93282 33954.

If you are in the manufacturing industry, you know how important it is to ensure the accuracy and quality of your products & packaging.

You also know how costly and time-consuming it can be to manually inspect every detail on your labels and cartons, such as barcodes, batch codes, pharma codes, and OCR.

Manual inspection can lead to errors, rejections, recalls, and customer dissatisfaction, which can damage your reputation and profitability.

Fortunately, there is a better way to inspect your products: using vision systems. Vision systems are automated devices that use cameras, software, and artificial intelligence to capture, analyze, and verify images of your products.

Vision systems can detect and correct any errors or defects in your products before they reach the market, ensuring compliance with industry standards and customer expectations.

One such state-of-the-art vision system available in the market today is Jekson Vision’s BPO system. Jekson’s BPO is a versatile and universal vision inspection system capable of detecting and verifying all major types of codes and artworks.

Fluent in reading a multitude of languages, it effortlessly processes data, facilitating seamless, internationally diverse operations. BPO is flexible to integrate various resolutions of cameras depending on the type of application.

BPO’s versatility shines through its adaptable camera system, accommodating VGA to 5 MP cameras. It also adapts to various illumination units depending on the type of application.

It ensures that every facet is meticulously examined, preserving brand integrity.

Some of the features and benefits of Jekson’s BPO system are:

• High-speed inspection of up to 1400 products per minute
• Multi-language reading of batch details
• Smallest camera with built-in illumination
• Automatic recognition of barcode types
• Smart OCR is capable of reading all types of fonts
• SAP integration for fetching batch details for non-serialized data

Jekson’s BPO system inspects and verifies barcodes, data matrix (2D codes), pharma codes, crypto types, and batch details. It also inspects logos and artwork inspection, label inspection, and color variations.

The system is easy to install, has 24×7 remote troubleshooting, is suitable for all cartooning and labeling machines, and meets all regulatory compliances.

By using Jekson’s BPO system, you can improve your manufacturing quality and efficiency by:

• Reducing human errors and increasing accuracy
• Saving time and labor costs
• Avoiding rejections and recalls
• Enhancing customer satisfaction and loyalty
• Boosting your brand image and reputation

If you want to learn more about how Jekson’s BPO system can help you achieve your manufacturing goals, contact us today for a demonstration and free consultation.

We will be happy to answer any questions you may have and show you how our vision system can transform your business.

Don’t miss this opportunity to take your manufacturing to the next level with Jekson’s BPO system!

Contact us at: marketing@jeksonvision.com or WhatsApp or call us at +919328233954

Russia also requires a Foreign Economic Activity Common Nomenclature (FEACN) code encoded on all 2D codes, along with GTIN, Serial Number, Batch Number and expiry date, verification keys, and verification codes (crypto code).

This is applicable to all medications, including OTC (Over-the-counter). It has specific norms for multi-level serialization & aggregation, i.e., individual units must be serialized, and a 2D barcode must be placed on the box or bottle; each batch must also be serialized with a 2D barcode on the box.

The owner of pharma goods must also create Universal Transfer Documents (UTD) at the moment of ownership and then transfer them to the CRPT. They require scannable codes on drug packaging and electronic reporting of transactions throughout the supply chain.

When you receive the crypto code from CRPT, print it as a 2D Matrix code with a minimum grade of C or higher as a print quality.

To establish the authenticity of digital identification codes, it is crucial to include crypto verification. The combination of GTIN/Crypto key/Serial Number/Crypto signature is extremely difficult to reproduce or guess.

It is also possible to authenticate offline through a secret algorithm that doesn’t require a database or internet access.

The Federal State Information System for Monitoring Drug Circulation (FSIS MDC) will oversee the serialization process. All supply chain members must register with the FSIS MDC and report all batch and serial numbers.

The regulations apply to contract manufacturing organizations (CMOs) and contract packaging organizations (CPOs) that import or produce drugs in Russia.

Manufacturers must be able to receive documents and notifications from the Russian Drug Circulation Monitoring System (MDLP), which is an electronic drug monitoring system managed by Russia’s Center for Research in Perspective Technologies (CRPT).

Manufacturers also need to communicate with Russia’s Order Management System (OMS) to manage the generation, receipt, and reporting of crypto codes.

Adhering to these comprehensive requirements is very complex, and your technical teams will need assistance. Jekson Vision is one of the leading service providers which has a proven track record in implementing Russia Serialization.

Connect with us at marketing@jeksonvision.com or WhatsApp us at +919328233954

In the intricate world of pharmaceuticals, medical devices, and consumer goods, the integrity of packaging stands as a sentinel of quality and assurance.

It’s not merely about aesthetics; it’s about safeguarding product excellence, fortifying brand reputation, and, above all, ensuring the well-being of consumers.

The advent of blister inspection systems has emerged as a technological bastion in this quest for packaging perfection. However, navigating the labyrinth of inspection solutions requires a discerning eye.

To guide businesses on this journey of packaging quality and regulatory compliance, we present an exhaustive checklist for evaluating blister inspection systems, delving beyond mere points to unravel the subtleties that define excellence.

1. Advanced Vision Technologies

In the world of blister inspection, where even the tiniest detail matters, having a keen eye for perfection is crucial. When looking for a blister inspection system, focus on those that embrace these cutting-edge vision technologies:

• High-resolution cameras: Utilizing advanced high-resolution cameras, modern blister inspection systems should capture even the most minuscule defects, ensuring an unparalleled level of accuracy in identifying imperfections.
• Color analysis capability: Look for systems equipped with the capability to analyze color variations in packaging, a feature that allows for the detection of subtle differences that might indicate defects.
• 3D imaging technology: The integration of 3D imaging technology should provide a comprehensive assessment of packaging, guaranteeing that no defect goes unnoticed, even on complex blister designs.

2. Defect Detection and Classification:

When seeking an effective blister inspection system, the ability to spot anomalies becomes a critical factor. Look for systems that possess a sharp eye for detecting irregularities:

• Pinhole detection: A robust system should excel in pinhole detection, identifying micro-sized holes or imperfections that could compromise the product’s integrity.
• Foreign particle detection: The system should be designed to detect foreign particles, preventing any contamination that might occur during the packaging process.
• Precise classification of defects: Beyond detection, a reliable solution should be adept at classifying defects, enabling targeted quality control interventions.

3. Data Analytics and Reporting:

Data is the currency of precision. When navigating the realm of blister inspection systems, directing your focus toward solutions that offer robust data analytics and reporting capabilities is imperative.

Look for systems that seamlessly amalgamate technology and information to provide you with a comprehensive understanding of your production processes.

Here’s what you should prioritize:

• Real-time data analytics: Look for blister inspection systems that provide real-time data analytics, offering insights into defect patterns and production efficiencies.
• Comprehensive reporting tools: The system should generate detailed inspection reports, allowing for thorough analysis and documentation of the inspection process.
• Integration with manufacturing analytics: Integration with manufacturing analytics systems should ensure a holistic quality control approach, facilitating data-driven decision-making.

4. User-Friendly Interface:

Navigating advanced technology doesn’t have to be a daunting task. When evaluating blister inspection systems, prioritize those that seamlessly blend cutting-edge capabilities with ease of use.

Look for systems that offer:

• Intuitive interface: Seek systems featuring an intuitive interface that simplifies system setup, monitoring, and adjustments, ensuring that operators of varying technical backgrounds can efficiently operate the system.
• Interactive visualization: The solution should provide interactive visualization tools that aid operators in defect identification and analysis, enhancing the overall user experience.

5. Integration with Production Line:

An inspection system that dances in sync with the production line is a true asset. An exceptional blister inspection system not only ensures meticulous defect detection but also seamlessly intertwines with the production line, orchestrating a symphony of quality and productivity.

Consider these critical features when assessing a blister inspection solution’s integration capabilities:

• Seamless integration: The blister inspection system should seamlessly integrate with existing production line equipment, minimizing disruption and optimizing production flow.
• Synchronized rejection mechanisms: The system should incorporate synchronized rejection mechanisms, swiftly removing defective products from the production process.
• Feedback loops: Immediate feedback loops should prevent further production of faulty items, ensuring minimal wastage and safeguarding consumer safety.
• Oscilloscope Software: To ensure quality and easy troubleshooting, Jekson System provides real-time monitoring machine integration signal with in-built software Oscilloscope

6. Regulatory Compliance:

In an age of stringent regulations, compliance is non-negotiable. When considering a blister inspection system, one must evaluate its capability to align seamlessly with these regulatory demands.

Look for systems that offer:

• Adherence to industry regulations: A dependable blister inspection system should adhere to stringent industry regulations and standards, ensuring that products meet the highest quality and safety benchmarks.
• Serialization and track-and-trace compatibility: The solution should be designed to seamlessly integrate with serialization and track-and-trace mandates, contributing to regulatory compliance.

7. Customization and Adaptability:

In the realm of blister inspection, where every product packaging is a unique entity, the ability of an inspection system to adapt becomes crucial. The following are key aspects to consider:

• Adjustable inspection parameters: Seek systems that offer the flexibility to adjust inspection parameters to accommodate various blister packaging types, sizes, and materials.
• Customizable settings: The solution should come with customizable settings, allowing for precise tailoring to meet the specific needs of different product lines.

8. Maintenance and Support:

Like a well-oiled machine, the effectiveness of a blister inspection system hinges on its continuous operation. To ensure unwavering performance, keep an eye out for:

• Regular updates and technical support: The provider should offer regular software updates and comprehensive technical support, ensuring that the system operates optimally and efficiently.
• Proactive maintenance services: Maintenance services should be designed to proactively identify and resolve any potential issues, minimizing downtime and ensuring continuous performance.

9. Integration with Quality Control Workflow

An inspection system is a pivotal player in quality control. Look for a blister inspection solution that harmonizes seamlessly with your quality management endeavors:

• Seamless integration with QMS: The blister inspection system should seamlessly integrate with quality management systems, streamlining quality control workflows.
• Collaboration with other inspection equipment: The solution should collaborate effectively with other inspection equipment, such as fillers and labelers, offering a cohesive quality control approach

10. Supplier Reputation and Experience: The Pillars of Trust

Ultimately, it’s about the people behind the technology:

• Reputation and experience: Consider the reputation and experience of the supplier, looking for testimonials, case studies, and industry references that vouch for their reliability and expertise.

Jekson Vision – Uniting Every Element of Excellence

As you embark on the quest for the ideal blister inspection system, remember that each element in this checklist is a building block of assurance. It’s a journey toward safeguarding your products, upholding industry standards, and maintaining the trust of consumers.

In this realm, where precision is paramount and excellence is the norm, Jekson Vision stands as the epitome of perfection. With solutions that embrace each facet of this checklist, Jekson Vision ensures that your packaging quality transcends boundaries.

The Windsor Framework is a new agreement that aims to ensure the continuity and stability of the supply of medicines in Northern Ireland after Brexit.

It is a complex and important topic that affects the health and well-being of millions of people.

In this blog post, we will explain what the Windsor Framework is, why it matters, and how Jekson Vision can help you comply with its requirements.

What is the Windsor Framework?

The Windsor Framework sets out the long-term arrangements for the supply of medicines into Northern Ireland.

It will ensure that medicines can be approved and licensed on a UK-wide basis by the Medicines and Healthcare Products Regulatory Agency (MHRA) and provides for the disapplication of European Union (EU) Falsified Medicines Directive (FMD) requirements for medicines marketed and supplied in Northern Ireland.

The FMD is a set of rules that aims to prevent counterfeit or falsified medicines from entering the EU market.

It requires medicines to have unique identifiers and tamper-evident features on their packaging, as well as to be verified and decommissioned at each point of the supply chain.

However, under the Northern Ireland Protocol, which is part of the Brexit deal, Northern Ireland remains aligned with some EU rules, including the FMD.

This means that medicines supplied in Northern Ireland would have to comply with both UK and EU regulations, which could create confusion, duplication, and delays.

To avoid this situation, the Windsor Framework allows medicines supplied in Northern Ireland to follow only UK rules, as long as they are labeled as ‘UK Only.’

This means that they do not need to have FMD features on their packaging, but they also cannot be exported or sold to any other EU country.

Why does the Windsor Framework matter?

The Windsor Framework is a significant development that has implications for both patients and businesses in Northern Ireland. For patients, it means that they can continue to access safe and effective medicines without disruption or shortages.

For businesses, it means that they can avoid the costs and complexities of complying with two different regulatory regimes.

However, the Windsor Framework also comes with some challenges and responsibilities.

For example, businesses need to ensure that their medicines are clearly labeled as ‘UK Only’ and that they do not cross the border into any other EU country.

This requires accurate and reliable track & trace and vision inspection solutions that can verify the identity, origin, and destination of each medicine package.

How can Jekson Vision help you?

Jekson Vision is a leading provider of track & trace and vision inspection solutions for the pharmaceutical industry. We have extensive experience and expertise in helping our clients meet the highest standards of quality, safety, and compliance in their markets.

We offer a range of solutions that can help you comply with the Windsor Framework requirements, such as:

• Label printing and verification systems that can print ‘UK Only’ labels on your medicine packages and verify their correctness and legibility. We have both Online & Offline solutions for the same.
• Track & trace systems that can generate unique serial numbers for your medicine packages and record their movements along the supply chain.
• Vision inspection systems that can check your medicine packages for any defects, damages, or tampering.
• Data management systems that can store and manage all the data on the cloud, which is related to your medicine packages, and provide reports and analytics.

With Jekson Vision’s solutions, you can ensure that your medicines are correctly labeled, tracked, traced, and inspected according to the Windsor Framework rules. You can also reduce the risks of errors, fraud, or penalties that could harm your reputation or profitability.

If you want to learn more about how Jekson Vision can help you comply with the Windsor Framework requirements, please contact us today at marketing@jeksonvision.com. We will be happy to discuss your needs and offer you a tailored solution!

The Drug Supply Chain Security Act (DSCSA) is a federal law that was enacted in 2013 to improve the security and traceability of prescription drugs in the United States. The DSCSA has a number of requirements that are being phased in over time.

Some of the requirements that will come into effect from November 2023 include:

• Interoperable electronic tracing of prescription drugs at the package level: This requirement will require all trading partners in the drug supply chain to be able to electronically trace prescription drugs at the package level. This will allow for the tracking of prescription drugs through the supply chain and will help to identify and investigate suspect or illegitimate drugs.
• Electronic submission of transaction information (TI) and transaction statements (TS): This requirement will require all trading partners in the drug supply chain to electronically submit transaction information and transaction statements to each other. This information will be used to track the movement of prescription drugs through the supply chain and will help to identify and investigate suspect or illegitimate drugs.
• Systems and processes to promptly respond to requests for transaction information (TI) and transaction statements (TS): This requirement will require all trading partners in the drug supply chain to have systems and processes in place to promptly respond to requests for transaction information and transaction statements from the FDA or other appropriate Federal or State official. This will allow the FDA to quickly investigate and respond to reports of suspect or illegitimate drugs.

These are some of the DSCSA guidelines that will come into effect from November 2023. Pharmaceutical companies and other trading partners in the drug supply chain should be prepared to comply with these requirements.

Here are some specific aspects of how serialization and aggregation can be used to achieve the goals of the DSCSA:

• Improving the security of the drug supply chain: Serialization and aggregation can make it more difficult for counterfeiters to introduce fake or adulterated drugs into the supply chain. For example, suppose a counterfeit drug is detected at a wholesale distributor. In that case, the distributor can use the serialization information to track down the source of the drug and take action to prevent it from reaching patients.
• Increasing the traceability of prescription drugs: It can allow for the tracking of prescription drugs through the supply chain. This can help to identify and investigate suspect or illegitimate drugs. For example, suppose a patient experiences a medication error. In that case, the pharmacist can use the serialization information to track down the source of the drug and to take action to prevent it from happening again.
• Enhancing patient safety: It helps to ensure that patients receive the correct medication. For example, if a patient is dispensed the wrong medication, the pharmacist can use the serialization information to identify the mistake and correct it.
• Reducing costs: Reduction of cost is associated with drug recalls and other supply chain disruptions. For example, if a drug recall is necessary, serialization and aggregation can help to identify the affected products and to track down the source of the problem.
• Improving compliance: By meeting the requirements of the DSCSA, pharmaceutical companies can demonstrate their commitment to the security and traceability of prescription drugs. This can help to improve their reputation with regulators and customers.

Some of the key steps that companies can take include:

• Evaluate their current supply chain: Before implementing any new technologies or processes, pharma companies should first evaluate their current supply chain to identify any gaps or areas that need improvement. This will help them to develop a more comprehensive and effective implementation plan. At Jekson Vision, we do exactly the same! We offer detailed consultation based on a detailed study that our subject matter experts do while interacting with your teams.
• Select the right solutions: There are a number of different solutions that Jekson has to offer to implement the DSCSA guidelines. Pharma companies should select the system & solutions that best meet their specific needs and requirements.
• System-Driven tracking and tracing drugs: Pharma companies need to develop a system for tracking and tracing drugs throughout the supply chain. This system should be able to capture and store all relevant data, such as the product identifier, lot number, and expiration date. Jekson Vision has a proven track record of offering Track & Trace Solutions across the globe for more than a decade. With a global level of exposure, we are sure to give you the right, customized, and robust solution.
• Implement appropriate security measures: Pharma companies need to implement appropriate security measures to protect the data that is used to track and trace drugs. This includes measures such as encryption and access control. With Jekson’s proprietary solutions, which are developed at its own dedicated development center, system security is easily implemented.
• Train staff: Pharma companies need to train their staff on how to use the new system. This training should cover all aspects of the system, including how to track and trace drugs, how to generate and submit reports, and how to respond to requests for information from the FDA. Once our solutions are implemented, we ensure that detailed staff training is done at your site.
• Monitor and update the system: Pharma companies need to monitor the system on an ongoing basis to ensure that it is working properly. They should also update the system as needed to reflect changes in the law or regulations. For this, Jekson’s renowned & cost-effective SLA comes into play, which keeps you secured and free of any tension.

By following the above steps, pharma companies can implement the DSCSA guidelines that will come into effect from November 2023. This will help them to improve the security and traceability of prescription drugs in the United States.

Contact us on mobile or WhatsApp at +919328233954 or write to us at marketing@jeksonvision.com to get customized solutions for your brand and book a demo to see how it works.

In today’s fast-paced world of smart packaging, businesses are constantly on the lookout for innovative solutions that guarantee product quality, regulatory compliance, and operational efficiency.

In the midst of this quest, one exceptional machine emerges—the BiSmart Intelligent Blister Inspection System, developed by Jekson Vision.

This state-of-the-art blister inspection system is revolutionizing the approach to smart packaging, setting new benchmarks for manufacturers worldwide.

Join us on a journey into the realm of smart packaging as we unveil the remarkable features and benefits of Jekson Vision’s BiSmart Intelligent Blister Inspection System.

In an era of rapid technological advancements, the packaging industry is experiencing a revolutionary transformation, and BiSmart stands at the vanguard of this evolution.

The Rise of Smart Packaging and the Imperative of Reliable Inspection

The increasing demand for smart packaging solutions has reshaped the packaging industry, paving the way for advanced technologies that enable enhanced product safety, authentication, and traceability.

In this context, blister inspection plays a crucial role in ensuring the integrity of packaged products.

As regulations become more stringent, manufacturers are under immense pressure to adopt reliable and efficient blister inspection solutions to meet evolving industry standards.

Introducing BiSmart: Empowering Excellence in Blister Inspection

Jekson Vision’s BiSmart represents a significant leap forward in blister inspection technology, offering a comprehensive suite of features designed to streamline the inspection process and optimise operational performance.

With its state-of-the-art capabilities and advanced functionality, it is revolutionizing how manufacturers approach blister inspection.

User-Friendly Interface and Robust Security Features

BiSmart’s user-friendly interface empowers operators to navigate the system with ease, ensuring seamless integration into existing production lines.

The intuitive design simplifies navigation and reduces training time, allowing operators to adapt to the system swiftly.

Furthermore, it incorporates robust 21CFR security features, providing a secure and compliant environment for pharmaceutical packaging.

The system’s stringent security measures instill confidence in manufacturers by safeguarding sensitive data and ensuring regulatory compliance.

AI-Based Teaching for Unparalleled Inspection Precision

BiSmart leverages the power of artificial intelligence (AI) to revolutionize blister inspection. Through an amalgamation of AI algorithms, it achieves unparalleled precision and accuracy.

By utilizing advanced cameras and computer algorithms, these systems can quickly and accurately identify even the tiniest of defects, ensuring that only high-quality products make it out of the factory floor.

First, with digital image processing, then the application of statistical techniques, and only recently, the use of artificial intelligence (AI) has projected us into a digital age where data has a central role in the development of the final solution.

The main advantages of using AI algorithms in industrial machine vision are accuracy, speed, automation, adaptability, and flexibility.

• Accuracy: AI-powered computer vision systems can identify and classify defects with a high degree of accuracy, often surpassing the capabilities of the most experienced human inspectors. This ensures a higher quality of the final product.
• Speed: Machine vision systems can inspect products much faster than human inspectors. This allows you to increase production capacity without compromising quality.
• Automation: AI enables complete automation of the visual inspection process, eliminating reliance on human inspectors and thus reducing the risk of human errors and the need for manual work.
• Adaptability and learning: AI-powered computer vision systems can be trained on large amounts of data to recognize specific defects or quality criteria. Furthermore, they can continue to learn and improve over time, reducing errors and adapting to new conditions or defects.
• Flexibility and customization: Machine vision systems can be adapted and customized to meet the specific needs of different industries and applications. This ensures that the systems are highly accurate and efficient at detecting defects specific to the industry in which they are used.

Configurable Exception Settings for Tailored Inspection Requirements

BiSmart offers effortless accessibility through various means, including keyboard and biometric data. This versatility streamlines the authentication process and minimizes time-consuming manual entry.

Additionally, it provides configurable exception settings, allowing users to tailor the system to their specific requirements.

This flexibility empowers manufacturers to address unique challenges and optimize the inspection process, enhancing efficiency.

Modular Configuration and OEE Reporting for Streamlined Operations

BiSmart’s modular design enables seamless integration into existing production lines, ensuring minimal disruption and maximum efficiency.

The system’s modular design also enables manufacturers to adapt and scale their operations to meet evolving market demands.

Furthermore, it provides comprehensive OEE (Overall Equipment Effectiveness) reporting, offering valuable insights into production efficiency, performance analysis, and downtime optimization.

These reports empower manufacturers to make data-driven decisions, identify bottlenecks, and drive continuous improvement.

Multilingual Support for Global Reach

Recognizing the global nature of the packaging industry, BiSmart supports multiple languages. This feature promotes effective communication and collaboration across diverse regions and markets.

Leveraging Cloud Storage and Real-Time Monitoring for Enhanced Productivity

BiSmart embraces the power of cloud technology, offering secure storage and efficient data management capabilities.

By leveraging cloud storage, manufacturers can access critical inspection data from anywhere, anytime, facilitating real-time monitoring and analysis.

The cloud-based architecture ensures seamless team collaboration, enabling rapid information exchange and streamlined decision-making processes.

Moreover, cloud storage enhances data integrity, eliminating the risks associated with local data storage, and provides scalability to accommodate growing data volumes.

Inbuilt Oscilloscope for Real-Time Monitoring of the systems

The BiSmart Software incorporates a game-changing oscilloscope feature, empowering users with real-time graphical visualization of signal data to monitor and troubleshoot blister machine operations efficiently.

This innovative capability drastically minimizes the setup time required for both the Blister Machine and Inspection System.

With the added flexibility to select assigned input-output pins and pulse duration, users can easily analyze and optimize their machine setup for enhanced performance.

To summarize, Jekson Vision’s BiSmart sets itself apart as an exceptional blister inspection solution.

Its intuitive user interface, AI-based teaching, configurable exception settings, modular configuration, and cloud storage capabilities make it a powerful tool for manufacturers seeking to achieve optimal product quality, compliance, and operational efficiency.

By adopting BiSmart, companies can streamline their packaging processes, mitigate risks, and enhance their brand reputation.

To harness the full potential of smart packaging and experience the benefits of BiSmart, don’t hesitate to get in touch with us by phone or WhatsApp at +91 9328233954 or email us at marketing@jeksonvision.com.

The pharmaceutical industry in India is gearing up for a significant regulatory change with the introduction of the Drug Amendment Act 2022 by the Ministry of Health and Family Welfare, Government of India, on January 18, 2022.

This act mandates that pharma companies producing 300 specified drugs comply with a set of 11 criteria aimed at enhancing drug safety and traceability.

As the implementation date of August 1, 2023, approaches, it is crucial for pharmaceutical manufacturers to understand the implications of this act and take necessary measures to ensure compliance.

It is high time we delve into the critical aspects of the Drug Amendment Act 2022, understand its significance, and explore how pharmaceutical companies can comply with its requirements.

What is the Drug Amendment Act 2022?

The Drug Amendment Act 2022 introduces a series of measures to strengthen drug regulation and combat counterfeiting in India.

Under this act, Bar Code or Quick Response Code (QR Code) is required to print or affix on the primary packaging labels of drug manufacturers.

In cases where there is insufficient space on the primary package label, the code can be printed on the secondary package label.

These codes store data or information that can be easily authenticated using a software application, ensuring the traceability and authenticity of the drugs.

Why do we need the Drug Amendment Act 2022?

The Drug Amendment Act 2022 holds immense significance for the pharmaceutical industry for several compelling reasons.

Firstly, it addresses the growing concern of counterfeit drugs, ensuring that consumers receive genuine and safe medications.

By implementing serialization and track & trace technologies, the act enables efficient monitoring of the drug supply chain, from manufacturing to distribution, thus minimizing the risk of counterfeit or substandard drugs entering the market.

This, in turn, helps to safeguard public health and strengthen the reputation of the pharmaceutical sector in India.

Compliance Requirements

Pharmaceutical companies affected by the Drug Amendment Act 2022 must comply with a set of 11 criteria outlined in the act.

For detailed information about the 300 drugs and 11 criteria specified in the Drug Amendment Act 2022,  please visit our detailed guide here.

These criteria encompass various aspects, including the printing of unique identification codes, maintaining an electronic record-keeping system, and establishing mechanisms for authentication and traceability.

Compliance with these requirements is essential for pharma companies to continue manufacturing and distributing the specified drugs after August 1, 2023.

Preparing for August 1, 2023

As the implementation date of the Drug Amendment Act 2022 approaches, pharmaceutical companies must prioritize their readiness for compliance.

It is crucial to assess existing processes, identify gaps, and implement suitable serialization solutions to meet the requirements outlined in the act.

The implementation of serialization and traceability solutions not only enhances drug safety and supply chain integrity but also contributes to the overall growth and development of the pharmaceutical industry in India.

Jekson’s India Serialization Solution

In the face of these regulatory changes, Jekson Vision provides a comprehensive India Serialization solution designed to assist pharmaceutical companies in meeting the requirements of the Drug Amendment Act 2022.

Our solution integrates advanced serialization technologies with state-of-the-art label printing machines, enabling the seamless implementation of serialization processes.

With the ability to generate and print unique identification codes, our solution ensures that each drug package is traceable and authenticated throughout the supply chain.

Beyond compliance, Jekson’s India Serialization solution offers several benefits to pharma companies. It streamlines the serialization process, reducing manual errors and enhancing operational efficiency.

Real-time data capture and analysis enable improved inventory management, supply chain visibility, and product authentication.

Furthermore, our solution is scalable and adaptable, catering to the diverse needs of pharmaceutical manufacturers.

The Drug Amendment Act 2022 marks a significant milestone in the Indian pharmaceutical industry, setting higher standards for drug safety and traceability.

As the enforcement date of August 1, 2023, approaches, pharma companies producing 300 specified drugs must gear up to comply with the act’s serialization and traceability requirements.

Jekson Vision’s India Serialization solution offers a robust and reliable platform to facilitate compliance while providing operational efficiencies and improved supply chain visibility.

By embracing serialization technologies, pharmaceutical manufacturers can ensure the delivery of safe and authentic medications, fostering trust among consumers and upholding the highest standards of the industry.