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West Regulatory Affairs (RA) has a goal of harmonizing site-specific Drug Master Files (DMFs) into a global document as the processes at different facilities are synchronized.
As part of this effort, RA has recently harmonized two of the Westar® RU Gamma Process DMFs into a single DMF, now titled Pharmaceutical Gamma Sterilization Process. There are no changes to the current manufacturing process and controls performed at the West facilities, and this action was only to consolidate multiple DMFs into a single harmonized DMF to reduce regulatory burden and to simplify the filing for customers buying gamma sterilized product from multiple sites.RA is pleased to announce that the following sites are now able to supply gamma sterilized commercial products under one harmonized process DMF with the appropriate regulatory filings in place.Pharmaceutical Gamma Sterilization Process DMF:
West Facilities:
Westar® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
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.<br />
Sterilization processes are fundamental and critical in the manufacturing of sterile pharmaceutical products. According to the US Code of Federal Regulations, “Drug product containers and closures shall be clean and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use."<sup>1</sup> When considering elastomeric components, common methods for sterilizing include steam and gamma. This is where the sterilized components with Westar™ Ready to use (RU) and Westar™ Select RU quality levels come in. Westar™ RU and Westar™ Select RU quality level products are supplied ready to be used and help simplify and speed up the drug manufacturing process while maintaining high standards of quality and safety.
West has been on a multi-year journey to evolve its manufacturing strategy based on customer needs. With an advanced global network of manufacturing sites, we work each day to improve our service to customers and help them to mitigate the risks of drug development and delivery.
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. <br />
<p><em>A scientific poster by: Clara Goodfield, Eugene Polini, Amy Miller and Wayne Curry</em></p><p><em>The ideal sterilization process destroys all microorganisms rapidly with minimal adverse impact on the chemical and physical properties of the elastomeric closure. Developing and validating an acceptable sterilization process is critical to the drug product quality. This study served to help understand the potential deterioration of physical and chemical properties, the possible impact to functionality and the potential changes to the extractable/leachable profile as a result of sterilization</em></p>
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