SAP Advanced Track And Trace For Pharmaceuticals
Every year millions of deaths occur around the world owing to adulterated drugs. Governments around the world are enacting legislations to fight the falsification of drugs – requiring serialization of pharmaceutical products and reporting to institutional databases and Supply chain partners and subsequently provide tracking and tracing of these products. One such legislation is Drug Supply Chain Security Act (DSCSA) in USA.
IT industries across the world are fighting to meet these requirements of Pharmaceutical companies, who wish to comply to Unique and Universally identifiable standards, i.e., GS1, through development of solutions. SAP Auto-Id Infrastructure (AII) and SAP Object Event Repository (OER) have been the two-part solution for this purpose for several years from SAP. However, the above software is limited in its reporting capabilities and installation complexities.
On Sept.15, 2015 SAP formally launched Advanced Track and Trace for Pharmaceuticals (ATTP) with the collaboration of 9 major pharmaceutical companies. SAP ATTP provides a Corporate Serialization Repository to facilitate pharmaceutical companies to generate serial numbers, transfer those serial numbers to packaging lines, and then track and trace the passage of drugs through the complete supply chain. It is designed and built specifically to address the expected data volumes, data query and regulatory reporting required as per The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines and related regulations.
SAP ATTP – Major features
- Seamless Integration capabilities with SAP Enterprise Central Component (ECC), third party warehousing and packaging products.
- Management of serial number created.
- Integration of Warehouse Management System (WMS) and Integration of Supply chain.
- Business and technical monitoring of all messages.
- Electronic Product Code Information Services (EPCIS) Repository of rules, events and serialization of numbers for querying & reporting.
- Reporting to regulatory authorities using Drugs Authentication and Verification Application (DAVA), a portal for Indian Drugs Authentication, Tracking and Tracing or a similar portal in other countries.
- Providing a network of pharmaceutical companies for information exchange.
- Country reporting packages and functionality to meet the needs of different countries.
Serialization: It is the process of Creating, Allocating and Assigning a unique identification number to finished products such as units, bundles, cases and pallets etc. at multiple levels or hierarchy.
- Serial Number is unique for the product, making it almost impossible to make a counterfeit product.
- Serial Number can be used in combination with other attributes of a product like Material Number, Batch Number and Expiry Date etc.
Brand protection – Combats the loss of revenue, reputation and customer trust that occurs in events such as cargo theft, pharmacy theft, counterfeiting, diversion and so on.
Reverse logistics – Includes gaining feedback to make improvements and to improve understanding of real reasons for product returns. Reverse logistics strategies can be used forrecalls, returns, withdrawals, chargebacks, rebates, shrink/loss recovery.
SAP ATTP came into existence as per the Drug Supply Chain Security Act (DSCSA) and other regulations that each pharma product is to be serialized and serial number has to be uploaded into Drugs Authentication and Verification Application (DAVA) portal. Electronic Product Code Information Services (EPCIS) is a global GS1 Standard (2D Barcoding) for creating and sharing visibility event data, both within and across enterprises. This standard ensures important information about a drug is accessible, accurate and easy to understand by all the stake holders.
SAP ATTP integrates SAP ECC transactional data, Brand owners (Wholesalers) and communicates with line master (packing line). The major challenge is that there is no provision to integrate the line master to SAP ATTP. Then the line master integrates with middle-ware like OPTEL, which in turn communicates with SAP ATTP.
This serialized information needs to be readily accessible and highly responsive to support business processes that require authentication, and to provide easy access for regulatory compliance, including investigations and statutory reporting.
Creating a global, scalable serialization architecture to manage a complete end-to-end business process is critical. The solution must be deployed rapidly, must be scaled quickly, and must manage the exchange of serialized information across your supply chain with no disruptions in day-to-day business activities.
SAP ATTP makes serialization of products simple which otherwise is a complex phenomenon involving international laws & regulations, IT and logistics. Serialization legislation is already in force in large markets, with China being the biggest. By 9th Feb 2019, all drug manufacturing companies in European Union (EU) must comply with the serialization regulation. DSCSA of USA prescribes 27th Nov 2023 as the deadline for complete unit level traceability throughout the whole supply chain.
SAP ATTP – Advantages:
- Leaner supply chain
- Improved BI through data collection and reporting
- Improved sales and operational planning
- Increased inventory accuracy
- More effective recalls
- Better product information to clinical personnel and patients
- Enhanced brand value
Drug counterfeiting is a crucial problem addressed by several countries. It requires multiple measures to protect the supply chain. The implementation of anti-counterfeit technologies is an important strategy taken up by several drug manufacturers and regulatory authorities. Over the next five to ten years, it is estimated that all developed and developing countries would implement these technologies. In India, tracking and tracing is implemented only for exported drugs. It is very essential to include provisions in Drug and Cosmetics Act for incorporating security measures in packaging of pharmaceuticals.
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