Packaging & Product Protection Featured Articles
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Leveraging An Application Managed Services (AMS) Provider For Pharma/Biotech Serialization Systems
11/16/2023
With the expansion of serialization requirements, including the need for Drug Supply Chain Security Act compliance, many pharma/biotech companies are turning to serialization technology systems to help them manage those specifications. This article shares the key benefits of leveraging an application managed services (AMS) provider as well as key considerations for selecting a provider.
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1 More Year For DSCSA Prep: Pros, Cons, & What To Do Next
10/30/2023
The FDA recently announced that they do not intend to take action to enforce drug distribution security requirements under section 82(g)(1) of the FD&C Act until Nov. 27, 2024. What are the pros and cons of this announcement, and what should we do now? This expert shares his perspective and recommendations.
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How CCIT Helps CDMOs Fulfill Their Commitment To Quality
10/3/2023
A lack of knowledge of container closure integrity testing (CCIT) could put a CDMO at a disadvantage compared to competitors, so it is critical to have a thorough understanding of CCIT.
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Choosing The Right Primary Container And Troubleshooting Issues
8/25/2023
Selecting the right primary container for an injectable drug product is critical. Discover how to identify relevant testing to de-risk your product development – and quickly uncover causes of failures.
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8 Benefits Of Vision Inspection In Manufacturing
8/7/2023
Manufacturing requires a high level of precision and accuracy to ensure product safety and efficacy. Here, we explore eight benefits that vision inspection brings to the world of manufacturing.
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Practical — And Crucial — Actions To Take Now For DSCSA Compliance
6/29/2023
Serialized data exchange, enhanced verification, and tracing, oh my! Many companies are still unprepared for full DSCSA implementation in November. Is your company one of them? Here are the important actions to take now.
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Breeze Through Surprise Audits — Take These 5 Actions Now
6/8/2023
Summer is here! That means you might hear the dreaded words, “Surprise! We are coming to audit you!” Whether it’s a client, supplier, or regulatory agency calling for an audit, those words can strike fear in even the most organized companies. But not if you're prepared by taking these five action items now.
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Transformative Shifts In Medical Device Package Quality Testing
5/30/2023
While the medical device industry continues to evolve to accommodate lifesaving therapies, advancements in deterministic testing technologies ensure medical device packaging integrity and sterile delivery to the patient.
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Inspection Technologies For Tablets And Capsules Packaging
3/28/2023
Inspection technologies play a crucial role in ensuring the safety, quality, and reliability of tablet and capsule packaging. Explore package integrity testing methods proven to be accurate and efficient.
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Increase In FDA Inspections + Whistleblower Complaints = Heightened Compliance Scrutiny
3/27/2023
We are seeing a significant increase in manufacturing facility inspections by the FDA and other health authorities globally. We are also seeing an uptick in whistleblower complaints. Why? And how can you navigate it? This article examines the issue.