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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 current pharmaceutical market has faced a variety of challenges, including increasing expectations for quality from end-users and regulatory agencies driven by concern for patient safety. While pharmaceutical companies are working to assure that new quality and compliance paradigms are met, a balance must be achieved between the reality of managing costs to provide a product that meets payer’s requirements and facilitating profitability in order to continue adequate business reinvestment.
In the prefilled syringe system, the plunger is in contact with the drug product during administration and the drug storage period, which may last up to two years and can affect the long-term stability of the drug product.<br />
West Regulatory Affairs (RA) has a goal of harmonizing site-specific Drug Master Files (DMFs) into a global document as the processes at different facilities are synchronized.
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