The Next Step After Serialization
Counterfeit medicine is a huge problem all around the world. It has been estimated that a considerable portion of products in the pharmaceutical market is fake and this number rises each year. These counterfeit medicines are a threat to the reputation and revenue of legitimate pharmaceutical manufacturers and, more importantly, they are dangerous for the health and safety of the public. Therefore, to fight counterfeit medicines and provide transparency in the pharma supply chain process, the regulatory authorities around the world have made it compulsory to implement traceability systems also known as Track and Trace Systems. The traceability systems mark the products with a unique serial number, following the GS1 standards, so that product is visible throughout the whole pharma supply chain.
A successful track and trace system can only be achieved with integrated serialization and aggregation processes. An effective Track and Trace system provides the visibility of the drug supply chain by making sure that the product can be traced back to its manufacturer along with all the channels it took to reach the end-user. This includes all points in the pharma supply chain such as wholesalers, distributors, and point of sale.
Many countries around the world have directly or indirectly defined aggregation along with the serialization in traceability operations. Turkey, a pioneer of the Track and Trace system, has made serialization and aggregation compulsory since 2012.
Brazil and South Africa will follow the suit by 2022.
The USA (DSCSA regulations) will require complete unit-level traceability system implementation by 2023 and onwards.
To understand why the authorities are regulating aggregation along with serialization in the traceability operations, it is necessary to understand what is pharmaceutical aggregation.
What is Pharmaceutical Aggregation?
How Does It Work?
Aggregation in pharmaceutical industries is defined as the process of building parent-child hierarchies between different packaging levels of the pharmaceutical unique identifier products. For example, when a serialized carton (child) is placed in a case (parent), a packaging hierarchy is built. As more serialized cartons are placed inside the case, their serial numbers are aggregated and related with SSCC (Serial Shipping Container Code). The SSCC is generated with the help of VISIOTT Traceability Software. The SSCC is printed on the label which is applied to the case. It contains information about all the cartons presents inside the case.
Advancing to higher packaging levels, the case becomes a child and the pallet becomes a parent. All the SSCCs of cases are aggregated and related with the pallet SSCC label which is then printed and applied to the pallet. The pallet SSCC label contains information about all the SSCCs of cases and thus all the serial numbers in each carton inside the cases.
As the parent-child relationship is now established, the SSCC label of pallet can be scanned at any point throughout the pharma supply chain. All the information about cases and cartons can be accessed easily without having to scan each carton separately.
Aggregation is a highly effective operation that saves time and resources when dealing with high quantities of products. Besides saving time and resources, it has many advantages as follows:
Serial Verification of Data
By scanning the code at various points through the pharma supply chain, the data can be verified with the predecessors. If there is any dissimilarity in the data, then the product has been compromised.
Faster and Efficient Recalls
If there are any concerns about some products then the products in question can be easily recalled. They can be efficiently returned without causing damage.
Decommissioning Multiple Units
If a pallet has been damaged but the information about the serial numbers has been already sent to the central database as commissioned serial numbers, then all the serial numbers in the damaged pallet can be decommissioned easily in bulk because there will be no need to decommission each serial number individually.
Increased Process Security
The pallets remain sealed until they arrive at their final destination. There is no need to open the pallet every time to check the products inside it. All the products can be known by just scanning the pallet SSCC label. As all the products remain inside the pallet, there is increased security of the process as none of the products will get misplaced, or lost.
Better Warehouse Management
It is easier to find the products. The product’s serial number can be tracked to the SSCC which will lead to the specific pallet or case or bundle where the product has been packaged.
Compliance with Regulations
Many authorities around the world require aggregation along with serialization.
It is apparent that aggregation simplifies Track and Trace operation throughout the whole process of the pharma supply chain. Important information can be shared and verified from manufacturer to wholesaler to distributor. It means that if the product appears elsewhere than the expected place of arrival, it is a counterfeit or a stolen product. Therefore it is clear that aggregation can help in fighting counterfeit medicines by tracing the product back to its manufacturer through the drug supply chain. As the importance of pharmaceutical aggregation is clear, it is also necessary to find the right company that provides the best pharmaceutical aggregation solutions. VISIOTT Traceability Solutions is the perfect partner with immense experience and knowledge of the industry.
Benefits of the VISIOTT Traceability Solutions
VISIOTT Traceability Solutions provides HIGH-QUALITY and COST-EFFECTIVE aggregation solutions. These are turnkey solutions that include software, hardware, and services. All the solutions are manufactured in ISO 27001 and ISO 9001 certified manufacturing facilities. VISIOTT offers an impressive portfolio of aggregation solutions for the case, bundle, and pallet.
The systems can scan serial numbers of each layer in the case and generate a related SSCC label. They can also scan the serial number from bundles with over-wrap and shiny films and generate an SSCC label to be applied to the bundle. The case SSCC label is also generated to be applied to the case. In last, a related SSCC label for the pallet can be generated and applied for building the highest parent-child hierarchy.
VISIOTT’s highly qualified engineers design these systems as per your hardware, software, and regulatory requirements. Thus these solutions can easily integrate into your production line. The systems are GAMP 5 validated and 21 CFR Part 11 compliant. They comply with all the regulations around the world such as FDA, EU-FMD, MDLP, ANVISA, SFDA, EPTTS, etc.
VISIOTT has never limited itself to the delivery of solutions, even has the best after-sales support available 24/7. All these distinctive features make VISIOTT your ideal partner for aggregation solutions.