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On August 6 and 7, 2019, USP hosted the Second Annual Workshop to explore current trends, initiatives and regulations for quality compounding. Members of the West Pharmaceutical Services, Inc. (West) Scientific Affairs and Strategic Marketing departments participated in the USP workshop and gained valuable insight into the key elements of the FDA’s efforts to improve the quality of compounded drugs.
Sara Rothman, Senior Policy Advisor with FDA’s Office of Unapproved Drugs and Labeling Compliance in the Center for Drug Evaluation and Research, Office of Compliance, presented the FDA’s perspective. Key takeaways from Sara’s presentation include:
West constantly stays abreast of the regulatory landscape in order to provide high-quality products and support to customers. For more information, please contact an Account Manager or Technical Customer Support (TCS) representative.
Even though glass syringes are predominantly used for primary containment of parenterals, the (bio)pharmaceutical industry continues to cope with certain limitations associated with glass containment systems. This is especially true when the drug is administered via prefilled drug-delivery systems such as auto-injectors or pens where glass cracks and breakage can be a serious risk for patients.
One of the most important aspects for choosing container closure system for parenteral drug products is to ensure an ideal fit between all components to maintain product sterility.
<span style="color: #000000;">Container closure integrity is defined as the ability and quality of a container closure system to provide protection and maintain efficacy and sterility during the shelf life of a sterile drug product. The ability of rubber components to prevent microbial ingress of parenteral containers can be measured by seal integrity.</span>
Have you successfully developed a drug product in a prefilled syringe and are now wondering how to get it on the European market?<br />According to the European Union Regulation (EU) 2017/745 (MDR) Article 1(9), a prefilled syringe (PFS) is identified as “a single integral product which is intended exclusively for use in the given combination, and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable” (1). According to 2017/745 Article 1(9), you must prove that the device part of your combination product complies with the appropriate General Safety and Performance Requirements (GSPRs) laid out in Annex I of MDR. As you can no longer do a self-assessment, you will need to reach out to one of the currently designated 43 Notified Bodies in Europe (2) to do the conformity assessment for you. The results of the assessment are then captured in the Notified Body Opinion (NBOp) which you are required to include in the submission file to EMA or your national competent authority.
Students from the <a>Downingtown STEM Academy</a>, ranked the most challenging high school in Pennsylvania by the Washington Post, shadowed West’s Ambassador Interns during the week of June 26. Interns Andrew Ciciriello, Beth Crawford, Marissa D’Amelio, Neal Geosits, Hannah Grubb and Luke Lawn were each paired with a student and asked to mentor them on career options and the transition from high school to college.
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