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At West, we are committed to safeguarding the health and safety of the millions of patients who use our products every day. This commitment is anchored in our Core Value of Leadership in Quality, which ensures we never compromise on quality because we know that patients are counting on us.
The saying of “Every Dose, Every Time – 100% Commitment” is visible throughout our global manufacturing sites, a reminder that supports our constant focus on quality.
This focus on quality includes excellence in manufacturing, scientific and technical expertise, and management. At the manufacturing level, this means producing clean, sterile, high-quality components designed to minimize disruption to the supply chain and to deliver safe, effective drug products to the market— and to the patient—quickly and efficiently.
Quality product and system controls are designed to ensure compliance with our high standards and applicable cGMP’s, ISO standards and regulatory requirements.
We continuously work to improve our customer satisfaction scores for quality and have established metrics in place to measure our progress, including:
Our Out of Specification (OOS) metric, which is OOS Complaints per billion pieces shipped, continues to show steady improvement, with a 2019 OOS score of only 6.6 complaints per billion pieces shipped—our lowest number ever since we commenced tracking this metric. West’s global sites hosted more than 300 customer audits in 2019, receiving less than one major observation per audit, an exceptional result.
Our continuously improving quality metrics are a testament to an unrelenting focus on our quality culture, which connects team members to the patients who ultimately use our products. This culture is driven by our Leadership in Quality Core Value as well as a cadence of Patient First Focus themed events and communications. West’s Global Quality Week in 2019 continued with this Patient First Focus theme, highlighting the importance of data integrity, and emphasizing the need for our team members to ensure quality in everything we do.
Product quality has always been a top focus for West— producing high quality product for our customers and patients is “what” we do. A recent focus has also been on the “how,” which is the quality of our processes. A key metric in monitoring our process quality is Cost of Poor Quality (COPQ), which captures scrap, rejects, rework, customer returns/credits, and yield losses.
We realize that our Core Value of Leadership in Quality not only applies to product quality, but to everything that we do—laboratory testing, services, administrative and business process, as well as manufacturing processes. Improving process quality improves COPQ and reduces variations, which in turn improves the quality of the output from the process. This makes the output more predictable, eliminating additional inspections, rework loops and other type of mitigation activities to assure product quality is achieved. Improving process quality reduces overall risk to West, our customers and the patients we serve.
Click here to view the full 2019 Corporate Responsibility Report.
Research in the area of cell and gene therapies started almost 40 years ago, however recently there has been a surge of activity including landmark regulatory approvals for therapies treating chronic and rare diseases. In 2017 and 2018 the FDA approved the first two CART-T cell therapies for cancer treatment and the first two gene therapies for rare diseases. All four of these cell and gene therapies were approved under the FDA Accelerated Approval Program, aimed at expediting approvals for life saving drug therapies. These regulatory programs have the potential to shorten drug development as much as 1-3 years. Currently, there are more than 1,000 regenerative medicine clinical trials underway globally<sup>1</sup>, and the market is expected to grow rapidly over the next 10+ years.
The pharmaceutical and biotech industries face many challenges when selecting the appropriate stopper, seal, and vial combination for a drug product. Further compounding these challenges is the manufacturing capability of each component supplier. Lot to lot variation can result in components that had maintained container closure integrity (CCI) and visual acceptance during development unexpectedly failing during production. Therefore, it is important to take a system approach when selecting vial container closure system (CCS) components and designing a fill-finish process. To minimize the risk for sterility failure and maximize performance, it is essential to understand not just the process, but also the historical and trending performance of the selected parenteral packaging components. As a result, West has built the DeltaCube™ Modeling Platform to facilitate data-driven selection and optimization of vial CCS components.
<p>It is essential for companies in the pharmaceutical industry to be prepared to comply with compendial changes as soon as they are enacted. USP Chapter <381> (<em>Elastomeric Closure for Injections</em>), which covers West elastomeric components, is scheduled to be reissued on January 1, 2018 as <em>Components Used in Injectable Pharmaceutical Packaging/Delivery Systems</em></p>
Measuring container closure integrity (CCI) of polymer–based containers and syringes is a challenge. Tracer gas leak detection (i.e., Helium-leak)—the method endorsed by USP <1207> (<em>Package Integrity Evaluation – Sterile Products</em>)—cannot be used directly, because gases permeate polymers. Helium permeates at a very high rate, in part due to its small size. As such, direct use of Helium-leak with a polymer-based system will result in a leak rate above that measured with a glass-based system, that may be misinterpreted as resultant from a non-integral system, but is actually from Helium permeation.
<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>
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