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West is pleased to welcome guest blogger Dr. Marla Phillips, Director, Xavier University. Materials and products used to serve the drug and device industries are supplied from areas all over the world. From raw materials such as sand to highly processed components for delivery systems, the materials that are used to create packaging systems are presumed to be safe. But how can pharmaceutical manufacturers be sure that incoming materials used in these products are consistently safe and reliable?
Through the Integrity of Supply Initiative, Xavier Health is developing Good Supply Practices (GSPs) for the pharmaceutical and medical device industries to provide solutions to increase the reliability of supply. Perhaps the greatest discovery revealed through the initiative to date is the paradigm shift that every area of dysfunction related to the reliability of supply is caused by and/or can be controlled by the manufacturers themselves, not their suppliers. It is through this greater understanding that our solutions will shift from increasing supplier controls to improving how manufacturers work with their suppliers. The solutions will be tied to return on investment, will be commensurate with risk-based need, and will provide cross-industry best practice options.
It is the mission of the Integrity of Supply Chain Initiative to determine the source of the dysfunction affecting the integrity of supply, and to implement sustainable solutions that can be tied to return on investment, including increased safety, improved quality and/or enhanced reliability.
Pharmaceutical manufacturers, and ultimately, the patients they serve – need a reliable and consistent supply chain of safe, quality materials and products to limit adverse impact on the end user.
However, research results generated by manufacturers through the Xavier initiative has revealed that most of the issues begin with dysfunctions caused by the manufacturers themselves.
Areas of identified improvement opportunities fell under three main themes:
Identified by pharmaceutical and medical device manufacturers and corroborated by suppliers, these themes help to identify dysfunction that can be mitigated or avoided through the improvement of internal supply practices and/or through harmonization across the industry.
In future blogs, I’ll address each of these themes and next steps to help ensure greater reliability in our supply.
Interested in learning more? Then register now for PharmaLink 2015! The conference, co-sponsored by the FDA and Xavier University, will be held on Xavier University’s campus March 24-27, 2015. Join us!
<p><em>Part 2 of the Good Supply Practices Series</em></p><p><em>West is pleased to welcome guest blogger Dr. Marla Phillips, Director,</em><em> Xavier University. This is the second installment in a four-part series on supply chain management.</em></p><p>In my previous blog, I mentioned the three overarching themes that need to be addressed to help ensure the integrity of the materials supplied throughout the pharmaceutical and medical device supply chains through the development of Good Supply Practices (GSPs).</p>
<p><em>Part 4 of the Good Supply Practices Series</em></p><p><em>West is pleased to welcome guest blogger Dr. Marla Phillips, Director, </em><em><span style="text-decoration: underline;">Xavier Health</span></em><em>, Xavier University. This is the fourth installment in a four-part series on supply chain management.</em></p><p>There is strong recognition that human factors play a large role in how the supply chain operates (as with everything else). Success and positive impact cannot be attained without simultaneously addressing what drives human behavior in this space. </p>
<p><em>Part 3 of the Good Supply Practices Series</em></p><p><em>West is pleased to welcome guest blogger Dr. Marla Phillips, Director, </em><em>Xavier University. This is the third installment in a four-part series on supply chain management.</em></p><p>At the outset of the Integrity of Supply Initiative, an assumption was that suppliers cannot consistently supply what is needed. However, it was discovered through our research that manufacturers often do not know what specifications are actually needed, do not involve suppliers in development discussions, do not explore the full expertise of suppliers, do not understand their own process well enough to know how the incoming material will impact their process, and do not ask for the process capability of their suppliers.</p>
<p>Last month, I gave an overview of how West’s IT strategy supports the “One West – Customer First” business strategy through three major investment areas:</p><ul><li>Customer Relationship Management, or CRM</li><li> Supply Chain Management, or SCM</li><li> Business Analytics and Dashboards</li></ul>
In order to ensure the best quality drug product and optimal patient outcomes, it’s important for drug manufacturers to foster a collaborative effort with their packaging suppliers from the beginning – and that means starting with the patient in mind. Understanding patient needs and how that drug will be delivered, whether through one of West’s delivery devices or some other device, will help determine the needs within the West manufacturing process.
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