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In the pharmaceutical and biopharmaceutical industry, customers are challenged with the need for higher quality product options and a flexible supply chain. Quality standards are everchanging, and to help customers meet regulatory filing complexity, West has developed next-generation quality for ready-to-sterilize (RS) and ready-to-use (RU) components in an effort to provide a solution for those challenges while establishing a new regulatory strategy designed for risk mitigation.
Westar® Select components are created with a simplified regulatory approach that moves away from individual site Drug Master Files (DMF) to a single process DMF inclusive of multiple sites. Westar Select RS components adhere to a single pharmaceutical wash DMF that applies to both West’s Kinston and Waterford facilities – serving to globally harmonize the process. This enables customers to purchase Westar Select components from our Kinston and/or Waterford facilities to flex our capacity without regulatory filing barriers.
The wash process in the Kinston and Waterford manufacturing plants has the same validation documents, simplifying the regulatory strategy. Harmonization between the sites enables customers to reference a single DMF as part of their drug filing which allows for flexibility in supply.
The global harmonization of Westar Select components provides customers with a global product portfolio that enables supply chain flexibility and business continuity support that delivers high-quality, consistent components with a tighter specification. To learn more about Westar Select Components click here or contact a West Technical Customer Service representative here to hear about our global harmonization efforts to simplify the customer journey.
In the latest installment of our video series, West on the Road, we travel across the Atlantic to our manufacturing facility in Eschweiler, Germany. There we meet Manager of Process Engineering Martin Rothstein, who says he’s impressed at how often he has encountered West products in his private life, whether visiting a family member in the hospital or during a vaccination appointment for one of his two small children.
On November 18, during a gala event at the Marriott Marquis Hotel in New York City, Senior Vice President and Chief Commercial Officer Karen Flynn was awarded a Silver Stevie® Award.
West is pleased to welcome guest blogger John Ragland, Jr., Chief Product Officer, <a href="https://healthprize.com/"><span style="color: #6d6d6d; text-decoration: underline;">HealthPrize Technologies</span></a>. This is the third installment in a series on the West/HealthPrize collaboration.
Today’s regulatory guidelines and requirements for pharmaceutical manufacturers are getting more specific and stringent, ensuring that drug products are safe and that there is no compromise with the possible use of unsuitable and/or non-compliant packaging components. For instance, regulatory guidelines require use of clean components (inclusive of secondary seals for this context) for sterile filling operations.
The other West Ambassador interns and I can all agree that this experience is far from what we imaged, in fact it is much more. From the West without Borders picnic to being assigned various projects, we are learning there are many aspects of a being part of a team in a global company.
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