Packaging & Product Protection Featured Articles
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Six Serialization Mistakes Pharmaceutical Companies Make
12/21/2020
This article examines mistakes that are commonly made in the planning and implementation phases of a serialization project and proposes a solution to avoid each of these issues.
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Implementing Improved Analytical Methods To Support Vaccine Quality
12/18/2020
Some of the new COVID-19-targeted vaccines are spurring the use of novel analytical technologies to support rapid and thorough characterization, which may help pave the way for other vaccine manufacturers to implement these technologies as well.
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Are You Prepared For The U.S. Enhanced Drug Distribution Security (EDDS) Requirements?
10/5/2020
The initial requirements of the Drug Supply Chain Security Act (DSCSA) were deliberately structured and timed to allow industry to thoughtfully design and implement the required capabilities in preparation for the pinnacle requirement, which goes into effect on Nov. 27, 2023: the implementation of Enhanced Drug Distribution Security (EDDS) capabilities.
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Intro To Product Inspection And Tracking For The Cannabis Industry
7/28/2020
As the cannabis market grows, so does tracking requirements. Look at some of the cannabis hardware and software packaging solutions that provide increased profitability and reporting accuracy.
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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.