Packaging & Product Protection Featured Articles
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FDA’s First DSCSA Warning Letter — A Closer Look
3/11/2019
The FDA issued the first warning letter related to the DSCSA amendments to the FD&C Act. This article takes a look at this warning letter and explains why pharma manufacturers should care.
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FDA’s DSCSA Pilot Project Program — Should You Participate?
3/4/2019
The FDA announced its intent to establish a pilot program to “share information, current practices, research, and ideas on the feasibility of establishing standardized documentation to be used by members of the pharmaceutical distribution supply chain to convey the transaction information, transaction history, and transaction statement to the subsequent purchaser of a product and to facilitate the exchange of lot level data.” The question for the industry is, should you participate in the pilot program?
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Transform With An Equipment Partner: Preparing For Serialization
10/16/2018
Factors to consider as your organization works to conform to the serialization guidelines.
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USP <1207> Updates Leak Testing Recommendations For Pharma Companies
10/2/2018
Package integrity is defined as a package’s ability to prevent product loss, maintain product sterility, and in some cases, prevent oxygen ingress or maintain sub-atmosphere headspace pressures.
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Risk Mitigation In Pharmaceutical Packaging And Serialization Operations
5/24/2018
Choosing the right packager for your products can be a daunting task and one that should not be taken lightly. Follow these tips to find a partner that is right for you.
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How Pharmaceutical Shipping Influences Logistics Trends
1/9/2018
Considering the changes over the last few years and looking ahead to 2018, there are four predictions for pharmaceutical shipping trends that will also likely influence logistics overall.
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What Does The Deferment In The DSCSA Deadline Enforcement Mean For You?
9/12/2017
Determine your plan now for serialization readiness to put the worries of DSCSA costs and timelines behind you and patient safety back where it belongs — at the forefront.
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Protecting Today’s Biologics With Gelled Phase Change Materials
9/6/2017
As the biologics market continues to grow exponentially, the limitations of today’s thermal packaging utilizing phase change materials could have a considerable impact on the timely delivery of safe and effective medication. Gelled PCM eliminate these limitations and offer a more dependable future for the biopharma industry.
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Understanding And Delivering Your EU Orphan Drug Launch
8/25/2017
Although the European marketplace presents a significant opportunity for innovative orphan drug companies to meet unmet patient needs, launching your drug product can present a real challenge.
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A Paradigm Shift In Container Closure Integrity Of Parenteral Drugs
7/25/2017
This latest evolution of HVLD aims to achieve a high level of closed container integrity (CCI) assurance across the entire range of parenteral products.