Clinical Supply Packaging Resources
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Validating The Stability And Durability Of Labels After Thawing From Cryogenic Temperatures
2/26/2019
One important element of working in cryogenic temperatures involves ensuring labels remain intact and securely adhered to packaging after application as product moves from ambient temperatures to cryogenic temperatures to thawing at the point of use. The following study serves as a model for the need to validate label stability and adherence and is an example of the many different types of validation studies we regularly conduct to mitigate risk for customers during all phases of an advanced therapy clinical trial.
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Is Your Clinical Supply Strategy Ready For EU CTR?
3/3/2022
One of the most significant changes in the new EU regulation is Annex VI, which covers changes in the labelling requirements for investigational medical products (IMPs). So, what are the implications of these changes and how will they affect outer immediate packaging?
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Smart Packaging Advances The Quality Imperative In Clinical Trials
Learn how the right partner can help seamlessly integrate smart packaging and move toward an enhanced, patient-centric trial experience, ensuring that study protocols are not compromised.
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Strategies To Achieve Labeling Harmonization Amid A Legal Entity Change
3/9/2023
A strong labeling team is vital to ensure successful navigation of the legal entity change process, including developing a timeline, executing data transfers, and mitigating compliance risks.
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A Supply Chain Management Solution Designed for Clinical Research
8/4/2023
In this use case, follow along the clinical supplies management journey to learn how GxP Inventory replaces fragmented, spreadsheet-based processes to optimize visibility, traceability, and compliance.
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The 10 Most Frequently Asked Questions On Glass: Part 2
2/20/2024
Read the second part of this series on the most common questions encountered by an expert focused in scientific affairs and technical solutions for glass.
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Functional Testing Summary Of Daikyo Crystal Zenith Nested Vials
5/24/2024
The Daikyo Crystal Zenith nested vials meet the exterior dimensions of the glass standard ISO 8362-1. The vials maintain CCI for up to 6 months and can withstand ultra-cold temperatures and drop conditions.
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How To Evaluate A Clinical Supply Chain Partner To Meet Vaccine Trial Needs
1/1/2022
When selecting a supply chain partner, due diligence is critical. This article highlights questions you should be asking to ensure you are selecting the right supply chain partner for your clinical trial needs.
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Benefits Of Electronic Labels: Investigational Medicinal Products
12/2/2022
When a new therapeutic drug, medical device, vaccine, or other investigational medicinal product (IMP) is developed, learn why a label must be on its packaging that provides relevant and important information.
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Optimized Laboratory Kitting Is Key To Successful Clinical Trials
5/18/2022
Clinical trials can be completely derailed by the absence of a single component, a lack of clarity in labelling, or errors in temperature-controlled logistics.