Andy Polywacz

VP, Quality & Regulatory Affairs

August 27, 2018

Westar® Select Components – Moving Toward Global Harmonization

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.

West Elastomer Components 

 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.