Drugs Serialization
Serialization Simplified: Enhance Drug Traceability and Safety
Drug Serialization & Traceability Solutions for Pharma
In the highly regulated and complex world of pharmaceutical manufacturing, ensuring product authenticity and supply chain integrity is paramount. ITRadiant specializes in comprehensive Drug Serialization and traceability solutions, empowering pharma manufacturers to meet stringent global mandates while enhancing operational control.
Our services are meticulously designed to implement robust systems that assign unique identifiers to every saleable unit, enabling end-to-end visibility across the entire pharma supply chain. We help pharmaceutical enterprises to transform regulatory obligations into strategic advantages, safeguarding patient safety, protecting brand reputation, and driving significant operational efficiencies.
Importance and Necessity
1. Combatting Counterfeiting – Serialization helps in fighting the proliferation of counterfeit drugs. By assigning unique codes to each product, manufacturers and regulators can trace and verify the authenticity of medicines throughout the supply chain. This ensures that patients receive genuine medications and protects the integrity of the pharmaceutical industry.
2. Enhancing Traceability – Serialization provides a detailed record of a drug’s journey from production to the end user. This traceability is vital for effective recall management. In the event of a product defect or contamination, serialized data allows for precise identification and removal of affected batches, thereby mitigating potential health risks.
3. Ensuring Compliance – Regulatory bodies across the globe, such as the FDA in the United States and the European Medicines Agency (EMA), mandate serialization requirements to enhance drug safety and security. Compliance with these regulations is not only a legal obligation but also essential for maintaining market access and avoiding significant fines.
4. Improving Inventory Management – Serialization aids in better inventory control by providing real-time visibility into stock levels and movements. This helps manufacturers and distributors optimize their inventory, reduce overstock or stockouts, and improve overall supply chain efficiency.
5. Streamlining Supply Chain Operations – With serialization, the pharmaceutical supply chain becomes more transparent and streamlined. Unique identifiers facilitate quicker and more accurate data exchange between various stakeholders, including manufacturers, wholesalers, pharmacies, and regulatory authorities.
Why Serialization Matters in Pharma
Trivia: The concept of unique product identification for pharmaceuticals gained significant global momentum following widespread concerns over counterfeit drugs and diversion. Early legislative efforts, like California’s e-pedigree law in 2004, paved the way for more comprehensive mandates such as the US Drug Supply Chain Security Act (DSCSA) of 2013 and the EU Falsified Medicines Directive (EU FMD) of 2019, fundamentally reshaping how drugs are tracked from factory to patient.
Significance: Drug serialization is no longer merely a compliance checkbox; it’s a critical foundation for patient safety and supply chain resilience. By assigning a unique, verifiable serial number (often a GTIN with a unique serial) to each individual drug package, manufacturers can:
- Combat Counterfeiting: Provide irrefutable proof of authenticity, making it significantly harder for illicit products to enter the legitimate supply chain.
- Enhance Traceability: Enable granular track and trace capabilities, allowing for rapid identification and recall of affected products in case of quality issues or adverse events.
- Improve Supply Chain Visibility: Gain unprecedented insight into product movement, optimizing logistics, reducing diversion, and improving inventory management.
- Ensure Regulatory Compliance: Meet complex, evolving mandates from authorities like the FDA (DSCSA), EMA (EU FMD), and other national regulatory bodies, ensuring market access.
Drugs Serialization
Global Compliance Challenges We Solve
Implementing a robust drug serialization program presents unique and formidable challenges for pharma manufacturers:
- Regulatory Complexity: Interpreting and adhering to diverse global serialization mandates (e.g., DSCSA interoperability, EU FMD data submission to national hubs, UDI for medical devices) requires specialized expertise.
- Data Volume & Management: Generating, managing, and exchanging billions of unique serial numbers, along with associated product and event data (EPCIS events), creates an unprecedented data management challenge.
- Integration with Manufacturing Lines (Level 2/3): Seamlessly integrating serialization solutions with disparate packaging lines, vision systems, and plant-level execution systems (MES/MOM) is technically intricate.
- Master Data Harmonization: Ensuring consistent and accurate master data (e.g., NDCs, GLNs, GTINs, batch numbers) across enterprise systems and with trading partners is crucial for data integrity.
- Trading Partner Connectivity: Establishing secure and reliable data exchange with a vast network of CMOs, 3PLs, wholesalers, and dispensers, often requiring complex onboarding processes.
- Operational Impact: Minimizing disruption to production efficiency and throughput during the implementation and ongoing operation of serialization processes.
ITRadiant addresses these challenges by providing end-to-end expertise, from strategic planning and system selection to complex integration and validation, ensuring your serialization program is robust, compliant, and operationally efficient.
Our Technical Capabilities: Driving Value & Compliance
ITRadiant approach to Drug Serialization is holistic, focusing not just on compliance but on leveraging serialization data for broader business benefits, ultimately enhancing ROI and mitigating risk.
- Ensured Compliance & Market Access: Our solutions are designed to meet current and emerging global serialization mandates (DSCSA, EU FMD, etc.), guaranteeing your products can reach their intended markets without disruption or penalties. This avoids costly fines and market exclusion.
- Enhanced Anti-Counterfeiting Measures: By implementing robust serialization and verification capabilities, we significantly strengthen your defences against counterfeit products, protecting your brand integrity and, most importantly, patient safety.
- Optimized Supply Chain Visibility: Leveraging event data from serialization, we provide granular, real-time visibility into product movement, enabling better inventory management, reducing stock-outs, and identifying potential diversion points.
- Streamlined Operations: While serialization adds complexity, our optimized implementations minimize impact on production throughput. We focus on efficient line integration and automated processes to maintain or even improve operational efficiency.
- Improved Recall Management: In the unfortunate event of a recall, serialized data enables rapid, precise identification of affected units, significantly reducing the scope and cost of recalls and enhancing patient safety.
Our Technical Prowess
ITRadiant distinct differentiators and comprehensive technical capabilities position us as your premier partner for Drug Serialization and anti-counterfeiting solutions:
- Deep SAP ATTP Expertise: We possess unparalleled expertise in implementing and optimizing SAP Advanced Track and Trace for Pharmaceuticals (ATTP), SAP’s purpose-built solution for serialization. This includes configuring master data, serial number management, event processing (EPCIS), and reporting.
- Seamless Level 2/3 Integration: Our engineers excel at integrating SAP ATTP (Level 4) with your manufacturing execution systems (MES/MOM – Level 3) and packaging line control systems (Level 2), ensuring flawless data exchange and serial number commissioning. This includes expertise with various line management systems and vision systems.
- Global Compliance Framework: We implement a robust framework for managing diverse global serialization requirements, including data reporting to national authorities (e.g., FDA for DSCSA, European Hub for EU FMD) and secure data exchange with trading partners.
- Master Data Harmonization & Governance: Our specialists ensure your critical serialization master data (GTINs, NDCs, GLNs, batch numbers, expiry dates) is accurately managed and harmonized across your SAP landscape, adhering to ICH Q7 and GxP principles.
- Trading Partner Onboarding & Connectivity: We streamline the complex process of onboarding trading partners, configuring secure data exchange mechanisms, and ensuring interoperability for track and trace data.
- Validation & Audit-Readiness: Our implementations are meticulously documented and validated to meet stringent regulatory requirements, ensuring your system is audit-ready for authorities like the FDA and EMA. We provide comprehensive validation packages (DQ, IQ, OQ, PQ).
- Post-Implementation Support & Optimization: Our SAP AMS services extend to serialization, offering ongoing support, continuous monitoring, and optimization to ensure sustained compliance and performance. We proactively identify opportunities for efficiency gains.
Real-World Business Impact
Pharma companies achieve significant ROI from serialization by transforming a regulatory mandate into a strategic asset. Beyond avoiding hefty non-compliance fines and market access restrictions, serialization drives value through enhanced anti-counterfeiting measures, safeguarding brand equity and revenue.
Improved track and trace capabilities enable precise, rapid recall management, drastically reducing costs and reputational damage. Optimized pharma supply chain visibility, leveraging EPCIS data, leads to better inventory management, reduced stock-outs, and minimized diversion.
Furthermore, streamlined line integration and automated processes, often facilitated by SAP ATTP, can improve operational throughput, turning compliance spend into efficiency gains.
Choose ITRadiant for unparalleled expertise in Drug Serialization and SAP ATTP. We deliver robust, GxP-compliant solutions that not only ensure audit-readiness but also transform compliance into a competitive advantage, optimizing your pharma supply chain from factory to patient.
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