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As the need for higher quality drug delivery and packaging components increases, customers are challenged to meet new standards and comply with additional regulatory requirements. To help our pharmaceutical and biopharmaceutical partners meet these challenges and reduce risk, West has developed next-generation quality for ready-to-sterilize and ready-to-use components.
Westar® Select components, the latest in West’s industry-leading Westar quality enhancement offering, helps reduce variability and its effects on drug quality, safety and efficacy. The new Westar Select components offer even tighter particulate specification, a defined Global Product Portfolio focused on component capability, and a simplified regulatory strategy. Westar Select components will be available through an optimized global manufacturing network with multi-site production capabilities to help ensure a continuous supply chain, while reducing regulatory complexity for customers.
With Westar Select components, customers get high-quality, consistent components with a single, global Drug Master File covering multiple West manufacturing sites.
Visit the Westar Select product page to learn more.
Westar® is a registered trademark of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.
West believes that, as a global organization, we have a duty and obligation to contribute to a sustainable future and that each of us, working together, can make a difference. While we know that sound environmental practices make good business sense, the underlying reasons behind our commitment are the many benefits these practices provide to our communities, now and for future generations. As a company with the mission to improve patient health, it stands to reason that we are equally committed to a sustained investment in creating a healthier environment.
We are pleased to announce our recent publication in the November/December 2019 Issue of the International Journal of Pharmaceutical Compounding. In the article “How to Qualify Container Closure Systems, Part 1,” we address how compounding pharmacies (503Bs) can qualify systems for intended use via container closure integrity (CCI) to meet FDA Guidance requirements.<sup>1</sup>
Patrick Curran<sup>1</sup>, Vinod Vilivalam<sup>1</sup>, Suzanne Kuiper<sup>2</sup> and Derek Duncan<sup>2<br></sup><sup>1</sup>West Pharmaceutical Services, Inc. and <sup>2</sup>Lighthouse Instruments B.V.<p>An increasing number of pharmaceuticals including vaccines, stem cells and proteins require cold storage to maintain efficacy prior to use. However, the ability to maintain container closure integrity (CCI) during cold storage is not completely understood. </p>
West is pleased to share a Q&A with Mark McElfresh, Vice President of Operations and Supply Chain at West contract manufacturing, that recently appeared in <em>Manufacturing Leadership Journal.</em><strong> </strong><strong><br></strong>
The Japanese Pharmacopeia (JP) has updated chapter 7.03 “Test for Rubber Closures for Aqueous Infusions” and the last date to transition to the new version is <strong>September 30, 2015</strong>.
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