Discover the importance of pharmaceutical serialization in ensuring product traceability, improving regulatory compliance, and preventing counterfeit drugs. Learn best practices and solutions for serialization.
Pharmaceutical Serialization plays an integral part in helping ensure the security and continuity of the pharmaceutical supply chain.
The pharmaceutical industry is entrusted with an enormous obligation to produce, distribute, and dispense drugs that are safe, effective and dependable. The implications are significant, with patient lives and well-being at stake. With this landscape, authenticity and traceability of pharmaceutical products are non-negotiable.
Many of these challenges have been met with pharmaceutical serialization, or the process of uniquely identifying and tracking an individual package of drugs. Apart from improving the compliance aspect in regard to stringent regulations, it also increases transparency of pharmaceutical products along the supply chain.
What is pharmaceutical serialization?
Pharmaceutical serialization basics at the lowest level; each saleable unit (a bottle, box, vial, etc.) of a drug product has a unique serial number. The serial number acts as a unique ID, which allows for tracking and tracing of products through the supply chain from manufacturer level right down to patient level.
The key components of serialization fully are as follows:
Identifiers: Every package of a drug is assigned a unique serial number that may also include the National Drug Code (NDC), batch number, expiration date, and a random or sequential serial number.
Data Matrix Codes:
Two-dimensional barcodes that are printed onto packaging providing critical information about the product. Data matrix codes are essential on all track-and-trace systems.
Serialization complies with global standards, such as those established by GS1, to provide uniformity and compatibility in labeling and data interchange.
Why is Pharmaceutical Serialization so Important?
Improved Compliance with Regulatory Requirements:
Pharmaceutical serialization is no longer just considered as an optional process. In most cases, it is made a regulatory requirement. In the United States, Europe, and around the globe, local drug regulators such as the FDA, the European Medicines Agency (EMA), and other national regulatory bodies have established serialization mandates. Compliance, however, is key to avoiding regulatory sanctions, and to being able to sell into markets.
Counterfeit Prevention:
Fakes are a serious danger to patient safety. Serialisation enables verification of the legitimacy of pharmaceutical products, making it extremely challenging for counterfeit products to enter the supply chain.
Product Recall Efficiency:
Serialization offers rapid and accurate identification of affected batches in case of a product recall or quality issue. Supply Chain Transparency:
Serialization promotes transparency across the pharmaceutical supply chain. The system makes it simple for manufacturers, distributors, and dispensers to confirm the legitimacy of the products they handle.
Improved Patient Safety:
Serialization is important in protecting the safety of the individual by protecting the integrity of pharmaceutical products. It assures patients the authenticity and quality of the medications they receive.
Pharmaceutical Serialization Compliance Solutions
Meeting pharmaceutical serialization requirements necessitates a multipronged strategy:
Robust Data Management:
Design a large-scale, reliable, and secure data serialization management system.
Maintain integrity of the data and access control for regulatory reporting and traceability
Serialization Technology:
Invest in serialization technology such as high-speed printing and inspection systems.
Look for technology that pairs well with existing manufacturing and packaging processes.
Regulatory Expertise:
Partner with Regulatory Experts Further on Serialization — Serialization requirements vary vastly by region, and it is important to work with regulatory experts aware of such complexities
The regulations will keep evolving — so be aware and adapt your serialization strategy to suit.
Supply Chain Collaboration:
Cascade partnership and collaboration agreements down the supply chain with wholesalers and dispensers of animal medicines.
Keep all partners aligned on serialization best practices
Training and Education:
Train Staff on serialization, data use and compliance
Cultivate organizational awareness of serialization.
On The Horizon: Pharmaceutical Traceability
The release of serialized drug products is just one part of a larger track-and-trace system that covers multiple moving parts of supply chain. This track-and-trace system allows real-time tracking of pharmaceutical products as they are transported from the manufacturer to the patient.
The essentials of a track-and-trace system include:
Data Exchange Standards: Compliance with global data exchange standards (e.g., GS1) to enable seamless interoperability between disparate supply chain participants.
Aggregation: The ability to bundle serialized items together into larger units (case and pallet level) while retaining traceability to the original package level
Data Repositories: Data repositories are secure repositories that contain serialized data, providing access to authorized parties for verification and reporting purposes.
Integration of serialization and traceability systems with other supply chain management tools, such as Enterprise Resource Planning (ERP) and Warehouse Management Systems (WMS).
International Collaboration:
Cooperation with global partners to ensure traceability over borders.
Conclusion: Maintaining Trust in the Pharmaceuticals
With increasing complexity of pharmaceuticals and global supply chains, pharmaceutical serialization is a ray of hope and transparency. The increased efficacy of regulatory compliance and traceability strengthens the reliability of the pharmaceutical sector.
You must serialize, but more than that, you must be committed to patient safety and ensuring product authenticity. Serialization will continue to be an important solution to maintain trust and keep patients around the world healthy as the pharmaceutical landscape evolves.
Contact BioBoston Consulting or visit our website today to learn more about how we can help your organization.
