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On August 6 and 7, 2019, USP hosted the Second Annual Workshop to explore current trends, initiatives and regulations for quality compounding. Members of the West Pharmaceutical Services, Inc. (West) Scientific Affairs and Strategic Marketing departments participated in the USP workshop and gained valuable insight into the key elements of the FDA’s efforts to improve the quality of compounded drugs.
Sara Rothman, Senior Policy Advisor with FDA’s Office of Unapproved Drugs and Labeling Compliance in the Center for Drug Evaluation and Research, Office of Compliance, presented the FDA’s perspective. Key takeaways from Sara’s presentation include:
West constantly stays abreast of the regulatory landscape in order to provide high-quality products and support to customers. For more information, please contact an Account Manager or Technical Customer Support (TCS) representative.
Selecting a container closure system (CCS) is an important part of the pharmaceutical commercialization process. It is important to ensure that the components selected are compatible with the drug product to be packaged; however, it is equally important to ensure that the components are compatible with each other. Here we provide background on the importance of correct pairing between vials and stoppers and showcase <a href="/zh-cn/products/vial-containment-solutions/stoppers/4040-lyotec-lyophilization-elastomer-stoppers">lyophilization stoppers V-50-I (13mm) and S-87-I (20mm) in the 4040/40 Gray formulation</a> that can be paired with any vial blowback geometry.
In our last update, we mentioned that we were using real-time data and analytics to guide content growth. Every six months we analyze which of our Knowledge Center categories are the most popular. If a category is heavily accessed, our experts in those areas work to deliver even more cutting-edge information for customers.
The Tech Group’s Vice President and General Manager, Mike Treadaway, was recently honored with the Spirit of Philanthropy Award at the Association of Fundraising Professionals Greater Arizona Chapter’s 30<sup>th</sup> Annual Philanthropy Leadership Awards Dinner. The celebration honors those who advance philanthropy with awards including the Spirit Award, which recognizes outstanding philanthropic contributions to nonprofit organizations.
It is essential to consider lifecycle management during the development of new drugs – especially in the evolving area of biologic drugs. The market demand for both ease of use, and patient-centric at-home administration, is driving the need for innovative container systems and delivery devices. Typically, drugs are launched in vials; continuous development often then enables launch in other formats, such as pre-filled syringes and cartridges. West is committed to easing this movement from container systems to delivery devices through its NovaPure<sup>®</sup> component portfolio of elastomer closures. NovaPure stoppers and plungers offer best performance and highest quality. Developed with Quality-by-Design principles, they use FluroTec<sup>®</sup> barrier film and B2 coating technologies.
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