Packaging & Product Protection Featured Articles
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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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Transportation Solutions For Cell And Gene Therapy Supply Chains
5/4/2020
Developing a strong supply chain for your cell and gene therapy can make your company a more attractive target for acquisition as well as a more competitive player in the commercial environment.
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CCI For Combination Products: Assembling The Package Integrity Profile For Autoinjectors
4/20/2020
Due to their complexity, combination products, specifically autoinjection systems, present unique challenges in implementing a container closure integrity (CCI) testing strategy. This is further complicated by a pervasive, though diminishing, tendency for companies to consider CCI only at the final product-package lifecycle stage, an approach where combination products will highlight the pitfalls.
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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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Package Inspection Guidelines For Sterile Medical Products
4/9/2020
Class III medical devices have a unique set of requirements and package characteristics that need a comprehensive approach to selecting the right inspection methods. A variety of inspection methods exist for medical package inspection that require a thorough understanding to ensure quality.
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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.