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West is pleased to announce the official opening of its new Waterford, Ireland facility, a global center of excellence for West’s advanced manufacturing network. The opening was celebrated on July 19, 2018, when customers and senior-level Irish government officials joined West executives at a ribbon-cutting ceremony.<br />
When evaluating the vial system for your drug product, how do you know you’re making good decisions about protecting the drug product while also meeting regulatory expectations for data requirements as outlined in ICH Q9? To illustrate how complex it is to determine how much data is enough to make good, sound, decisions on your vial containment system, two 20mm container closure systems (CCS) were evaluated with the primary difference being the hardness of the rubber vial stopper. The designs were identical for each stopper, meaning the specifications, nominal dimensions, and other major features were the same.
This is part two of a three-part series about how recent updates to ICH Q2(R2) and Q14 can be applied to the development and validation of leachables methods. You can find part one <a href="/blog/2024/october/drug-packaging-extractables-leachables-guidelines">here</a>.
Many of the newer biologic products being developed are for long-term administration in chronic disease conditions, including oncology, autoimmune disorders and high cholesterol. Historically, these biologics have been administered by costly intravenous (IV) injection in a hospital, clinic or doctor’s office.
This past February, our team members around the world came together to help fight hunger in their local communities during our fifth annual global food drive. As the global community navigates the evolving challenges of the COVID-19 situation, having a stable food supply is even more important. We are proud of our team members for their incredible generosity. Their donations are needed now more than ever.
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