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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.
<p>It is essential for companies in the pharmaceutical industry to be prepared to comply with compendial changes as soon as they are enacted. USP Chapter <381> (<em>Elastomeric Closure for Injections</em>), which covers West elastomeric components, is scheduled to be reissued on January 1, 2018 as <em>Components Used in Injectable Pharmaceutical Packaging/Delivery Systems</em></p>
<strong>My greatest achievement is founding West without Borders*</strong><br />I’ve worked at West for 21 years! One of my friends approached me and said he would love it if I joined West. He kept telling me what a great company West was and eventually I agreed. I loved the job in the sales department because I got to work with a lot of bold personalities. I’m very outgoing and talkative and so are account managers.
Need immediate shipping of stoppers or seals? West has an efficient niche operation for small quantity fulfillment: our facility in Lititz, Pennsylvania. For those seeking samples, small quantity fulfillment for research and development needs or just a few components, Lititz offers off the shelf, convenient, fast and friendly customer service.
Diane Paskiet, Director, Scientific Affairs, will present at two sessions during the <strong>2012 PDA Annual Meeting. The meeting will be held from April 16-18, 2012 at the JW Marriott Desert Ridge Resort in Phoenix, Arizona.</strong>
Combination products open up new vistas when it comes to delivering innovative therapies to patients in need, but teams bringing these products to the market face a number of significant hurdles. Recent surveys conducted by West at workshops held in PA and AZ revealed some of our customers’ biggest challenges. This is the final of our three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.
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