Packaging & Product Protection Featured Articles
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Merck, Walmart, IBM, & KPMG’s FDA Blockchain Pilot: What We Learned
6/17/2020
IBM, KPMG, Merck & Co., and Walmart successfully completed an FDA pilot program that demonstrated how blockchain technology can be used to help meet the Drug Supply Chain Security Act (DSCSA) requirements to verify, track, and trace prescription medicines and vaccines distributed within the U.S.
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DSCSA, Blockchain, & The Pharma Supply Chain — Where Do Things Stand?
5/27/2020
As the requirements for serialization and track & trace become more challenging to implement as we approach 2023, blockchain, by providing data integrity throughout the supply chain, becomes a more attractive solution to reducing the probability of errors occurring.
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Helping Pharma Manufacturers Overcome DSCSA Interoperability Pain Points
4/13/2020
With the FDA guidance documents and requirements of the Drug Supply Chain Security Act still unfolding, there is a growing need for sectors in the supply chain to align on how to meet various aspects of the law.
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Are You Ready For A DSCSA Audit? 5 Steps To Ensure The Answer Is “Yes”
3/16/2020
During an FDA audit, you're asked questions about the U.S. Drug Supply Chain Security Act and how you offer and share your T3 data with downstream trading partners. Do you answer confidently, or hold your breath and gulp?
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Microorganism Challenges On Online Water Bioburden Analyzers: Pitfalls & Best Practices
3/2/2020
This the second article in a two-part series on conducting microorganism challenge studies using online water bioburden analyzers (OWBAs) in a laboratory setting. Part 1 discussed two different experimental approaches that have been successfully used for microorganism challenges. This second article explores the six pitfalls to avoid and four best practices to follow during execution of microorganism challenge tests.
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Experimental Methods For Microorganism Challenges On OWBA
2/17/2020
While implementing online water bioburden analyzer (OWBA) technology might seem straightforward, several aspects of preparing microbial challenges can easily derail the best intended experimental design.
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Aggregation 101: Connecting The Dots Between Pharma Serialization And Track-And-Trace
8/19/2019
From “serialization” to “coding” to “track-and-trace,” the pharmaceutical industry is rampant with terms that point to the quest for transparency. The latest of these is “aggregation,” a burgeoning method of data collection aimed at simplifying inventory and the supply chain. While still in its infancy, the technique can help to combat counterfeiting, theft, inefficiencies, and confusion as a whole. Yet, with every new process comes challenges, requiring manufacturers considering aggregation to seek best practices for implementation.
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Next Steps For Serialization In The Pharma Supply Chain
7/22/2019
The industry has made unprecedented progress and addressed several challenges to ensure compliance with global pharmaceutical serialization and traceability requirements. While these requirements contain further regulatory milestones on the horizon, manufacturers, distributors, pharmacies, and other parties in the pharmaceutical supply chain must systematically adopt serialization in their normal business operations.
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DSCSA’s 2023 Interoperability Requirements: Don’t Just Check The Compliance Box
6/27/2019
The Drug Supply Chain Security Act (DSCSA) requires creation of an interoperable system by 2023 to facilitate the sharing and gathering of transactional information back to the packaging at the original manufacturer for authorized trading partners or government agents in the event of a suspicious or illegitimate product. How will this system work and what components and governance will be required?
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Russia's New Serialization Regulations: What Pharma Companies Need To Know
4/18/2019
This article explains the challenge the new Russian traceability regulations for the pharma industry, and how all participants in the supply chain must properly prepare to ensure that they become compliant within this new environment.