Category Archives: Big Data

4 reasons why pharma serialization needs the Blockchain

Blockchain in Pharma
Due to regulatory mandates, the Pharma industry has identified Product Serialization as a key to reducing the amount of counterfeit drugs entering the supply chain. Serialization utilizes applications and systems to track and trace the channeling of prescription drugs as they move throughout the entire supply chain. Serialization provides a series of unique identifiers (ie National Drug Code + Unique Serial Numbers) for identifying drugs that may be traced from the API (Active Pharmaceutical Ingredients) Suppliers all the way to the patient. What serialization is focused on is based on these 4 factors:

1. Providing Visibility and Control within the entire supply chain
2. Product Verification
3. Product Traceability
4. Reduction in Counterfeit Drug Production

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iSolve – Blockchain Innovation for BioPharma

3D printing of medical products – FDA provides guidance to manufacturers

3D printing in healthcareDecember 4, 2017 – The U.S. Food and Drug Administration (FDA) on December 4 released a new set of recommendations for creating medical products using 3D printers. The guidance details the agency’s stance on device design, testing, and quality system requirements.

For a relatively new technology, 3D printing has a wide range of clinical applications, such as building functionally accurate replicas of complex anatomical structures and facilitating surgery simulations to restore hearing loss, remove stroke clots, and repair hip disorders. The rapid evolution of this technique has led the FDA to release an early policy framework to help manufacturers bring 3D-printed models to the market more efficiently.

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