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In 2016, West reached another quality milestone -- ISO 15378 (Primary Packaging Materials for Medicinal Products) certification for manufacturing facilities in North America. These facilities now join the already-certified facilities in Europe and Asia Pacific regions.
Products certified are rubber stoppers, rubber plungers, and seals (aluminum and plastic). ISO 15378 specifies requirements for the design, manufacture, and supply of primary packaging materials for medicinal products (i.e., materials used in pharmaceutical packaging that have direct contact with the product). ISO 15378 comprises two individual standards: ISO 9001 (West approved in 2009) and Current Good Manufacturing Practice (in the US: 21 CFR 210 and 211 for Drugs, and 21 CFR 820 for medical devices). With this certification, West customers worldwide can have an even higher level of confidence in the quality of West manufacturing and in the quality of West products.
ISO 15378 can be found here.
Marisa Leuzzi, Senior Specialist, Global Communications, from our Exton Headquarters, is one of the growing number of coronavirus survivors. Her experiences with her illness is not uncommon – but what she did after her recovery to keep her family whole is remarkable.
Developing a SARS-CoV-2 vaccine presents numerous and unprecedented challenges; prominent among them are greatly accelerated timelines. Ordinarily for a new drug product, there is sufficient time for selection/evaluation of the vial/stopper packaging system – one that guarantees quality and safety from manufacture through delivery. This is not the case for a SARS-CoV-2 vaccine where the primary packaging system must be chosen quickly, creating a higher risk.
Each June, West recognizes Pride Month, which promotes and supports the self-affirmation, dignity, equality, and increased visibility of the Lesbian, Gay, Bisexual, Transgender and Queer or Questioning (LGBTQ) community.
An extraction study is sometimes thought of by customers as an expensive and time-consuming exercise for filing. However, extractables studies are more than that. Performing an extraction study provides a thorough understanding of the materials used. It is a study that takes into account the primary packaging components and provides an understanding of the chemical species that may potentially come out over the shelf-life of a product.
<em>Welcome to Tech Talk, our latest feature from blogger Beverly Prohaska, Vice President, Global Information Systems. These features will discuss how West uses information technology internally and externally to help ensure customer satisfaction. Look for Tech Talk to appear regularly on the West blog.</em>
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