Establishing Best Practice Qualification Metrics For Smart Shipping Containers
Wernher von Braun, the father of modern rocketry famously stated, “one test is worth a thousand expert opinions.” The FDA has put their own regulatory...
Tagged: qualification
Ensuring cold chain remains cold and controlled room temperature remains controlled!
Qualification testing for the newest additions to the World Courier Ground Europe suite of vehicles has just been completed at Cambridge Refrigeration Technology (CRT) and...
Quality Process Ensures Thermal Packaging Reuse
This is the first of a two-part blog discussion about the challenges in, and value derived from, a temperature-sensitive packaging reuse program. There are many...
Qualification and Validation of Single-Use Shipping Systems
As the biotech industry evolves, there are mounting concerns about the transportation, security, and robustness of cell-culture media, intermediate, or bulk drug substance (BDS). Safe,...
Applying GDP to Biologics
Mary Foster, Pharm.D, USP Chair – PSD Expert Committee 2015-2020, presented a workshop on the applications of Good Distribution Practices to biologic shipping at the...
Challenges and Benefits of Using ISTA’s Standard 20 for the Development of ISC’s
This article is written by Ed Church and Eric Hiser, President Emeritus, and Vice President at ISTA respectively: ISTA Standard 20 Revision 2.0 is a...
Worst case scenario simulation in validation/qualification of transport containers
Having said that, along with providing monitoring and validation systems, we enjoy delving a little deeper into some of the issues that come up in the validation applications of...
