Article

Why serialized track and trace is necessary for healthcare packaging?

Topic: Business NetworkingPublished November 11, 2020
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The healthcare and pharmaceutical sectors go through a lot of challenges in their manufacturing, operations, and supply chain management processes. The US Food and Drugs Administration (FDA) emphasis that companies implement track and trace systems to improve the security of prescription drugs to customers. Implementation of electronic track and trace for prescription drugs through serialization will eliminate the counterfeit products over a period of time. rnUnique identification through serialization helps to identify who manufactured the product and where which wholesaler has sold to hospital or pharmaceutical retailers and to which customer it has been prescribed. Serialization provides the ability to track and trace the lifecycle of drugs and medical devices in the system end-to-end. The US Food and Drug Administration insists on an e-pedigree electronic document that contains the full history of entire batches that are manufactured and then prescribed to patients. The e-pedigree helps to avoid the prescription drug from being misbranded, counterfeited, sold after expiry, stolen, diverted, and/or contaminatedrnHow does a track and trace method improve security?rnA track and trace system enhances security by: • Providing complete information about the life cycle of the prescription drug, from where and when it is manufactured, re-packaging information, when and where distributed, and when it is prescribed and when it is sold. • Satisfying accurate compliance and regulatory requirement questions such as “What, Where, When and Who” • Precisely Locating prescription drug batches i.e. where they are distributedrn• Enabling the opportunity to recall a particular batch which is reported as having a product failure or having not met standardsrn• Identifying the prescribed drug is counterfeit, stolen, contaminated, etc. • Detailing the multi-container packaging item-level information rnHow do track and trace work?rnTrack and trace work in the following ways: • Generate and tag a unique serialization number for manufactured drugs. • Scan serialization number and store in a centralized database whether the product is distributed or non-distributed. • Update serialization data in a centralized inventory database. • Re-packagers, Wholesalers, and healthcare bodies can have the ability to validate the serialization when they perform transactions. • Each time a transaction for serialized drugs is performed, the transaction drug history is updated in the e-pedigree system.rnWhy implement a serialized inventory solution?rnThe following are strong reasons for implementing the serialized inventory solution: • Scan uniquely identified objects through serial numbers and barcodes etc. • Seamless integration with ERP, CRM, and other business softwarern• Track and Trace the complete lifecycle of supply chain management from end-to-end. • Prescribed drugs tracking and authentication is enabled at the item level, batch level, and GTIN level • Track and trace pallet, carton box, and containers • Allows tracking of historical data and multi-level hierarchy information of prescribed drugsrn• Quickly Identify batch failures, recall and alert relevant drug stockholders to remove the product from the shelf and return to wholesalers or manufacturers. ERP Gold as your pharma track and trace solution provider offers a serialized inventory solution that allows the full track and trace of pharmaceuticals throughout your supply chain and beyond to your end consumer. We offer a pharmaceutical serialization inventory solution that is fully compatible with the ERP software to work for all your track and trace needs.

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