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This is the first in a series of posts that will discuss the major issues that pharmaceutical manufacturers should consider when evaluating a packaging component supplier’s regulatory support.
Pharmaceutical manufacturers face ever-increasing requirements in order to gain regulatory approval for their medicinal products. Health authorities place expectations on the application holder to demonstrate control of all aspects of their manufacturing process and product, including suppliers of critical components, such as excipients and container closure components. While the supplier bears responsibility for complying with relevant standards, regulatory agencies have increasingly looked to application holders to demonstrate adequate quality control on their suppliers.
Given the regulatory expectations placed on application holders, it’s become more important than ever for them to carefully assess their suppliers. While pharmaceutical manufacturers routinely evaluate suppliers for quality-related considerations, it’s equally important to understand the scope of the support that they can provide throughout the drug development, approval and post-approval lifecycle. This information may not necessarily show up in a quality audit, but it can make a significant impact to the efficiency of the application holder’s review and approval processes.
As an industry leader in pharmaceutical packaging components and delivery systems, West Pharmaceutical Services has developed a comprehensive model for providing regulatory support to our customers in the pharmaceutical and biologics industries. This model is designed to provide them with support throughout all phases of their development lifecycle, from initial component evaluation through to post-approval management of their drug products.
In subsequent posts, we’ll discuss questions that pharmaceutical manufacturers should consider when evaluating the regulatory support that they can expect from a packaging supplier, such as:
In the following series of posts, we’ll take a closer look at each of these questions in more detail and discuss what to look for when evaluating a packaging supplier for your medicinal products.
The misson of West Regulatory Affairs is to provide customers with industry-leading support for their global regulatory needs. Please click here to learn more.
<p>In 2015, West Pharmaceutical Services, Inc. (West) announced that two materials of construction of the West STERI<span>LIZABLE</span>BAG™ packaging system will change:</p><ul><li>DuPont announced improvements to the manufacturing of Tyvek® 1073B Medical Packaging Material (using latest flash-spinning technology).</li><li>West’s polyethylene supplier announced discontinuation of current product.</li></ul>
Today’s business environment demands a seamless and continual transition of digital experience to conduct business and engage various stakeholders in the same way we conduct the rest of our lives outside work. The experience expectation is consistent across devices of choice from phones to tablets to laptops. That’s why West partners with the world’s top pharmaceutical, biotech, device and diagnostic companies to embrace technology that supports the patients they serve with online resources and tools to better manage their health. In turn, we’re looking to support our customers with digital tools to help speed the research and development process of bringing life-saving medicines to patients that need them.
Since its inception in 2011, the <a href="http://www.dasd.org/STEM"><span style="text-decoration: underline;">Downingtown Science, Technology, Engineering and Mathematics (STEM) Academy</span></a> has quickly earned the ranking as the number one high school in the state of Pennsylvania. With the STEM Academy located in the same district as West’s corporate headquarters, and a strong corporate culture of giving back to the community, a partnership between the two organizations was a natural fit.
The U.S. Food and Drug Administration recently issued a draft guidance, <a href="http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM346181.pdf"><span style="text-decoration: underline;">“Glass Syringes for Delivering Drug and Biological Products: Technical Recommendations to Supplement International Organization for Standardization (ISO) Standard 11040-4 (Draft).” </span></a>The document relates to issues encountered with glass Luer lock syringes when connecting to Luer fittings, including needles, needle-free Luer connectors, adapters and transfer units.
Deep-rooted in West’s culture, the health and safety of our team members has always been our top priority. And this remains consistent and strong despite the challenges brought on by COVID-19. Recently, our manufacturing plant in Sri City, India achieved 2,000 recordable incident free days, which is a tremendous milestone that demonstrates the team’s collaboration and commitment to safety at all levels of staff, from management to the plant floor.
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