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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.
By working by the side of our customers early in the drug development process, we are able to clearly understand what the specific containment and delivery requirements are for their drug product and select the appropriate packaging and delivery systems and materials. These early conversations allow us to align capabilities across the globe to meet high-quality expectations throughout the entire manufacturing process.
For example, we need to consider the particle load throughout the supply chain – including other facilities, materials and processing involved in the production and delivery of the drug product – to ensure that we’re mitigating any additional burden that may exist later in the process that could impact the final quality. West takes an active role in supporting our pharmaceutical partners in this process, working collaboratively to develop a solution for the total supply chain.
In addition, quality standards are incredibly important when it comes to the combination of emerging drug molecules and delivery devices. Previous standards didn’t necessarily take into account the unique containment needs of biologics or other large molecule drugs. Additionally, old standards didn’t address the total drug containment and delivery system, but instead focused on individual components, such as stoppers and vials. It’s a completely different supply chain, and the standards need to be updated to address the needs around current drug molecules and delivery systems as well as future therapeutic offerings.
Working by the side of our customer, we can ensure that patients are always in the forefront of the production process, and that the quality of our manufacturing reflects the need for optimal patient delivery. When we understand better how our products will be used and what’s needed to align the capabilities, we can meet or exceed the quality expectations needed for our customers and ultimately the patient.
The revision to the United States Pharmacopeia (USP) General Chapter <1> Injections, Labeling on Ferrules and Cap Overseals standard becomes official on December 1, 2013. The revision will limit printing to <span style="text-decoration: underline;">only</span> cautionary statements on the top surface of the ferrule or cap overseal of a vial containing an injectable drug product sold within the United States. Seals with the embossed “Flip-Off” or printed with other non-cautionary labeling will not be compliant with this new standard.
<span style="color: #333333;">Technology is becoming a common component to any drug delivery mechanism. With West’s ongoing partnership with connected health expert, <a href="/sitecore/service/notfound.aspx?item=web%3a%7b91ADE0E1-ABB4-4B9C-BC44-C84AF2B9D310%7d%40es-ES"><span style="color: #0000ff; text-decoration: underline;">HealthPrize</span></a>, a new course to improve patient outcomes has been charted. By connecting West <a href="/es-es/products/self-injection-platforms"><span style="color: #0000ff; text-decoration: underline;">drug delivery systems</span></a> with the training, education and rewards from the HealthPrize model, we are addressing some of the most fundamental challenges surrounding adherence.</span>
We are pleased to announce that our Scientific Insights Lab team members, Liang Fang and Marissa Rase, received the 2021 Fred Simon Award, and its Chief Scientific Officer, Fran DeGrazio, received the 2021 Edward Smith Packaging Science Award at the 2022 PDA Annual Meeting in Dallas.
Part 1 of this two part blog series, gave a high-level overview of the new ICH guideline <em>Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management</em>. In part 2 of this blog series, some of the key takeaways will be discussed in more detail. <em>Q12</em> is intended to help companies demonstrate increased product and process knowledge, and understand which post-approval changes will require a regulatory submission, as well as the level of reporting for each category.
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