Issue link: https://www.e-digitaleditions.com/i/1462272
www.biopharminternational.com Quality and Regulatory Sourcebook eBook March 2022 BioPharm International 31 It took a few years and a lot of work, but pharma manufacturers are now barcoding nearly all their prod- uc ts accord i ngly. A n nua l a sse ss- ments conducted between 2017–2020 by AmerisourceBergen, McKesson Pharmaceutical, and Cardinal Health, in collaboration with GS1 US, doc- umented steady progress in barcode implementation. Each year, the big three wholesalers scanned product bar- codes in three different facilities and evaluated them for correct application of the required data standards. The 2020 assessment found over 90% of scanned packages and cases met all the labeling requirements, and the success rate has likely improved since then (1). READY, SET… Now that the products a re seria l- ized and barcoded with standardized product information, systems interop- erabilit y is the remaining lynchpin for meet ing t he DSCSA's intent. All trading partners must be able to record, capture, read, and exchange the product data contained in the barcode, in addition to other track- ing information such as locations and events such as shipping, receiving, and more. Combined, all that information provides a history of a product's jour- ney through the supply chain. The chain of custody, product information, and related supply chain events can then be traced back when needed—as in the case of a recall or adverse event. Suppliers and wholesaler/distrib- utors need to establish systems com- patibility and conduct rigorous testing to ensure viable data exchange on the front end of the supply chain. Then, they will be able to progress testing throughout the supply chain to ensure traceability and interoperability all the way to the f inal point of sale. This includes many thousands of clinical and retail facilities, large and small, with a wide range of IT capabilities, infrastructure, and preparedness for receiving and leveraging the data. ESTABLISHING DOWNSTREAM CAPABILITIES DSCSA's interoperabilit y require- ment places new responsibilities on the downstream partners who receive and dispense the medications. Many of the industry's smaller clinical orga- n iz at ions a nd pha r mac ies do not current ly have compatible systems they will need for data capture and e xc ha nge. Intensive col laborat ion between manufacturers, wholesaler/ distributors, providers, and dispensers is needed to bring them on board. The FDA draft guidance, Enhanced Drug Distribution Security at the Package Level under DSCSA, states that dis- pensers should be able to respond to FDA data requests within one day and that clerical errors such as miss- ing data should be resolved in three business days (2). While data errors or discrepancies are being resolved, the product cannot be sold. Wholesalers will become accountable for verifying the unique identifier of returned prod- ucts before they can be placed into inventory for resale. Dispensers will only be allowed to receive products with 2D Data Matrix barcode and product identifiers in accor- dance with the regulation. To meet this requirement, pharmacies will need 2D barcode scanners connected to supply chain data systems containing prod- uct information that can be exchanged between trading partners. RECORDING TRANSACTIONS AND SHARING DATA Beyond the barcode, full traceabil- ity requires an accurate record of supply chain events (shipping, receiving, etc.) in a product's digital history. Industry is moving for ward with the use of Electronic Product Code Information Services (EPCIS), for creating and shar- ing transaction data about the movement of products though the supply chain. F ina l ly, t he GS1 Globa l Data Synchronization Network (GDSN) is a standards-based solution that enables trading partners to share product mas- ter 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 facilitates fast and easy retrieval of product iden- tification, origin, and chain of custody events. Combined with the use of addi- tional standards for location identifica- tion, event recording, and data sharing, it will enable dispensers to readily track orders and incoming shipments, plan and maintain inventory based on real- time information, and utilize that data Quality and Regulatory Sourcebook Regulations: Supply Chain DSCSA's interoperability requirement places new responsibilities on the downstream partners who receive and dispense the medications. No amount of data will be of any use if it is not pure, trusted, accurate, and complete to begin with.