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Regulations and guidance on combination products continue to evolve both domestically and abroad. As the regulatory guidance and expectations around drug-device combination products continues to develop, the topic of Essential Performance Requirements (EPRs) has been applied to drug-device combination products in the United States market. EPRs should be chosen based on a risk-based process and documented to show they are appropriate for the specific combination product application. This includes addressing risk-based scientific and technological considerations of the combination product system. Understanding how to identify EPRs as well as determining the analytical approach and control strategies for EPRs is critical to the development of a combination product. Extractables and leachables analysis of the materials in devices and primary containment systems for combination products is also a key factor and needs to be part of the testing strategy.
This March, West and its Women’s Initiative Network (WIN) are proud to join organizations around the world in celebrating International Women's Day and Women’s History Month to recognize female achievement. We are especially proud to celebrate our female team members’ invaluable contributions to West & the pharmaceutical and manufacturing industries at large.
<span>The carnival season, also referred to as the “Fifth Season,” is one the most celebrated traditions in the Rhineland of Germany where West’s German plant and office sites are located. </span>
Andrea Straka, Senior Technical Account Specialist, will present “Sterilization Effects on Elastomer Characteristics and Functionality in Sterile Parenteral Drug Products” at the PDA Annual Meeting in San Antonia, Texas, April 7-9, 2014.
West Pharmaceutical Services, Inc. (NYSE: WST) is pleased to announce that <a href="/pt-pt/services/contract-manufacturing">West's contract manufacturing,</a> has received a 2015 Manufacturing Leadership Award in the Engineering and Production Technology Leadership category from Frost & Sullivan’s Manufacturing Leadership Council.
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