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West is committed to partnering with and providing analytical and technical support for customers so that they can successfully develop drug products and deliver them to patients.
To support this commitment, West Analytical Services, LLC has decades of experience and expertise in four areas that are critical to the performance of packaging components and delivery systems, as well as the compatibility and fit with the drug product. These areas comprise not only having staff with the right technical expertise and expert-level knowledge of all industry regulations, but also state-of-the art facilities, examples of which are:
*Full details and more at website
Knowing the ever-changing regulatory landscape, and having the expertise and facilities, West Analytical Lab is uniquely positioned to partner with customers to design, execute and interpret studies needed to help their drug products move most efficiently and safely to patients. The right study, performed the right way, gives not just data, but answers.
Visit the relaunched West Analytical Services section on westpharma.com to see more on this, and see case studies about how West has helped customers achieve success.
<p>By William and Suzette Rishel</p><p><em>Bill and Suzette Rishel are team members at West’s Jersey Shore, Pa., facility. Bill serves as Value Stream Lead and Suzette as a Quality Assurance Inspector.</em></p>
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.
<p>Amy Miller and Jennifer Riter</p><p>Extractables from elastomeric components become an issue even before a pharmaceutical drug makes contact with the elastomeric component. The suitability of the elastomer and the drug product needs to be taken into consideration at the development stage of the packaging and delivery system for the drug product. The potential for an extractable to leach into the drug product and the impact that leachable will have on the drug’s stability, efficacy and toxicity needs to be scientifically evaluated. </p>
Injectable drug products have stringent requirements for the presence of visible particles. However, there is currently no regulatory guidance for visible particles related to packaging components. Instead, specifications are established between suppliers and customers.
Drug shortages put patients at risk. Adverse health consequences can occur quickly when shortages make maintaining and/or complying to a therapeutic regimen difficult. In a recent <a href="http://www.nature.com/clpt/journal/v93/n2/full/clpt2012220a.html"><span style="color: #0000ff; text-decoration: underline;">paper</span></a>, Center for Drug Evaluation and Research (CDER) director, Janet Woodcock and her CDER colleague Marta Wosinska offered insight into the challenges CDER faces in choosing a course of compliance action when shortages of critical drugs occur. In the paper, CDER officials cited quality issues as the largest cause (56 percent) of drug shortages in 2011.
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