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At West, patient safety is the utmost concern. Intuitively, one might not think that Project Management can have an impact on patient safety – but it does – a very important impact. West Analytical Services LLC partners with customers to design and perform studies that help to enable the safest, and most efficient, delivery of drug products in West components/systems.
Project Management plays a key role in this partnership, and uses a defined, robust process for consulting with customers to manage these important studies. The first aspect of this role is to ensure a clear understanding of customer needs – both short and long term. Definition of these needs becomes the critical backbone for the study design that comprises strategy, objectives and agreed-upon milestones.
This study design is assembled by Product Management through collaboration with experts from Analytical Services, Technical Customer Support and the customer, with a focus on obtaining the right information and managing costs effectively. Executing the study then requires coordination of the efforts of Analytical Services staff and facility/equipment resources. Projects can vary in length – from 1 week to 5 years. As a study progress, data may necessitate a design change, which Project Management manages promptly.
A study well planned and executed delivers the right information on time, reduces risks, and helps to ensure safe and efficient delivery of drug products. The Analytical Services’ Project Management team is proud to play a key role in this.
For more, visit the Analytical Services page on the website or contact Jennifer Raab, Manager of Lab Project Management Office or a Technical Customer Support representative.
At West, we have adopted the philosophy that there are no IT projects, only business projects. Even business projects with a high dependence on IT are still business projects that require a business case with a measurable return on the investment. During the past year, West has been working to develop a unified project and portfolio management process. The initiative’s main goal is to ensure that we derive the full value from all business investments, including those that require IT enablement.
There are many benefits associated with the use of combination products (e.g., SmartDose® and SelfDose® Drug Delivery Platforms). Since combination products are often patient centered, they are designed to be convenient, assist in maintaining a drug therapy from home, and help to enable better compliance. To ensure these benefits, developers must formulate and execute a proper design verification study to minimize impacts by unknown risks. <br />
<p>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.</p>
Ensuring the safe containment of sensitive drug formulations requires a thorough evaluation of the container closure system. Selecting the packaging components requires knowledge about not only the drug formulation's requirements, but also the components’ material properties. Chemical compatibility of components with the drug formulation is key. Proper selection of components will provide the right closure design, assist with handling and help ensure container closure integrity throughout a drug product’s shelf life. Managing these factors well is critical, and West can help.
Ophthalmic drug products (ODPs) present a special challenge for the measurement of extractables and leachables (E&amp;L) due to the presence of multiple leachables sources. ODPs typically are packaged in labelled, semipermeable polymer (e.g., low density polyethylene) containers (i.e., primary container) and stored in cardboard containers (i.e., secondary container) along with instructions for use. The polymer, label, cardboard and paper are all possible sources of leachables.
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