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Extractables and leachables (E&L) pose a potential risk to patient safety. Both pharmaceutical companies and regulatory agencies have rising concerns regarding E&L, which has led the Center for Drug Evaluation under the China Federal Drug Administration (CFDA) to release a new standard for public comment (December 30, 2016): Technical Guideline for Compatibility Study of Chemicals and Elastomer Closures. The compatibility study discussed therein focused on E&L.
As a world leader in pharmaceutical packaging, West has a rich history and deep understanding of this subject. Last year, in the Pharmaceutical Packaging Regulation and Technical Open Symposium, which was co-organized by West Scientific Affairs and CNPPA (China National Pharmaceutical Packaging Association), Diane Paskiet, Director of Scientific Affairs, shared insights on E&L, as well as suggestions for the China technical guideline.
Diane discussed:
At West, patient safety is the highest priority. For more information on E&L, and how West can design and execute studies to evaluate E&L issues to promote patient safety visit the website, our Knowledge Center, or contact a Technical Customer Support representative.
QbD, CQA, QTPP,FEA – what does it all mean? Quality by Design (QbD) can be confusing, but it really doesn’t have to be. QbD was designed to promote an understanding of the product and manufacturing process starting with product development. When designing and developing a product using QbD principles, manufacturers must define desired product performance and identify Critical Quality Attributes (CQAs). The product and process is then designed to meet those product attributes, which leads to understanding the impact of material attributes and process parameters on the CQAs and identification and control of sources of variability. As a result of this knowledge, a company can continually monitor and update its manufacturing process to assure consistent product quality.
West is honored to celebrate Black History Month with educational opportunities and ongoing discussion as One West Team. We strive to build and maintain a culture where we value each other as fellow human beings; our policies and practices are just, inclusive and equitable; and all feel a sense of belonging.
We are very pleased to announce that two of our sites in Asia Pacific have received two additional safety accreditations recently, which further demonstrates and acknowledges our team’s continuous commitment to health, safety, and environment throughout West and the industry.
Come one, come all to the 2014 West without Borders campaign! From preliminary planning to the final one-ring circus, the 2014 West without Borders campaign in Kinston, N.C., was a whole lot of clowning around in the name of a good cause. This year, Kinston team members supported three charities: Relay for Life Kids’ Walk, Kid’s Cafe and Shriners’ Hospital for Children’s Transportation Fund.
When combined with the industry trends of increased regulatory scrutiny and higher focus on patient safety, risk management, and compliance, the market is seeing an increased need for high-quality drug delivery systems such as prefillable syringes.
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