Pharmaceutical Technology - March 2022

Pharmaceutical Technology March 2022

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Pharmaceutical Technology QUALITY AND REGULATORY SOURCEBOOK EBOOK MARCH 2022 43 product cannot be sold. Wholesalers will become accountable for verifying the unique identifier of returned products before they can be placed into inventory for resale. Dispensers will only be allowed to receive prod- ucts with 2D Data Matrix barcode and product identifiers in accordance with the regulation. To meet this requirement, pharmacies will need 2D barcode scanners connected to supply chain data systems containing product information that can be exchanged between trading partners. Recording transactions and sharing data Beyond the barcode, full traceability requires an accurate record of supply chain events (shipping, receiving, etc.) in a product's digital history. Indus- try is moving forward with the use of Electronic Product Code Information Services (EPCIS), for creating and sharing transaction data about the movement of products though the supply chain. Finally, the GS1 Global Data Synchronization Network (GDSN) is a standards-based solution that enables trading partners to share product master data in a fully automated way. With GDSN, stakeholders can establish an authoritative data source to align product information across their IT systems and with their trading partners. Data quality Barcode scanning replaces manual data entry with digitalized and automated data capture—which, when successful, eliminates operator error. It fa- cilitates fast and easy retrieval of product iden- tification, origin, and chain of custody events. Combined with the use of additional standards for location identification, event recording, and data sharing, it will enable dispensers to readily track orders and incoming shipments, plan and maintain inventory based on real-time informa- tion, and utilize that data to manage expirations, recalls, and verified returns. However, no amount of data will be of any use if it is not pure, trusted, accurate, and complete to begin with. Accurate product and location iden- tifiers, properly formatted according to industry standards, are essential. Many organizations are currently running old or proprietary systems and identification schemes, and many others could be using outdated or incorrect data. Trading partners need data they can trust, knowing it is accurate, complete, and always up to date. Multiple data sources must have consistent core information, which also must be synchro- nized for collaboration between organizations. That's why full adoption of data standards is an absolute necessity. When adopted across industry, GS1 Standards provide a common language and one source of truth that trading partners can ref- erence and understand interchangeably. Creating and maintaining trusted data is an on- going process that never ends. Without trusted data, traceability falls apart. Master data must be scrupulously scrubbed and curated; trusted prod- No amount of data will be of any use if it is not pure, trusted, accurate, and complete to begin with. Trading partners need data they can trust, knowing it is accurate, complete, and always up to date.

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