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The environment for developing an injectable drug device combination product (CP) is dynamic from a regulatory and technical perspective. At the center of it all are the patients and their needs. West is pleased to announce the publication of its review manuscript that provides a detailed overview of best practices for this kind of development program. It considers technical and regulatory aspects and can be used as a foundational document for drug formulators, scientists and engineers working in this area.
Creating a holistic, well rounded approach that puts management of risks at the center of development will be critical to address key CP issues, including:
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Awareness of the ever-changing technical and regulatory landscapes in the pharmaceutical industry is an essential element of West’s focus on the safe and efficient delivery of drug products. For more on how West can support CP development, contact an Account Manager or Technical Customer Service (TCS) representative.
The International Conference on Harmonisation (ICH) has issued <em>Guidelines for Elemental Impurities</em> to limit patient exposure to potentially toxic elements above a specified limit during their course of treatment.
As part of the 2010 West without Borders campaign, employees in West’s Exton, Pa., headquarters raised funds to aid Canine Partners for Life (CPL), an organization dedicated to training service dogs, home companion dogs and residential companion dogs to assist individuals who have a wide range of physical and cognitive disabilities. One of the many bonuses to working with the organization was an opportunity to name one of the service dogs. After a vote, the name “Star” was chosen.
Organizations today are far more vulnerable to cyber threats due to the digital information and technology that are so heavily integrated into the daily workplace. The attacks themselves, which target both information and critical infrastructure, are becoming far more sophisticated.
January 27th of 2023 was a memorable day. That was when the United States Pharmacopoeia (USP) posted a Notice of Intent to Revise in their Revision Bulletins<sup>1</sup> that caused a wave of discussion. What was this notice and why was it so remarkable?
As the need for higher quality drug delivery and packaging components increases, customers are challenged to meet new standards and comply with additional regulatory requirements. To help our pharmaceutical and biopharmaceutical partners meet these challenges and reduce risk, West has developed next-generation quality for ready-to-sterilize and ready-to-use components.
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