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Employees at West’s Eschweiler, Germany, facility celebrated the holidays with a party that had some very generous results. The party took place on December 15, 2012, with more than 520 employees attending and participating in a lottery for three superb prizes, including a flat-screen television, digital camera and gift voucher for gas.
The result? Three very happy employees and more than €4,000 raised to aid Fortschritt, an organization that helps to care for children and teenagers with cerebral disabilities.
“It was a very special project,” said Helga Bayer-Steguweit, who helped to organize the party. “And a wonderful way to say ‘happy new year’ to children in need in our region.”
The pharmaceutical industry’s focus on extractables and leachables from packaging/delivery systems began during the mid-1990’s. Today’s regulatory agencies are more educated about the process, and drug product formulations have become more complex, which makes the need for robust extractables and leachables programs more critical than ever. In fact, failure to properly evaluate extractables and leachables has had a negative impact on many pharmaceutical companies, e.g., late-stage stability failures, submission delays, and recalls. To avoid this, the first question to ask is – “where do I start?”
The level of particles in parenteral pharmaceutical formulations is a critical quality attribute. This is no surprise; the clinical consequence of their presence can be very severe, including fatality. In the major pharmacopeia, from the US, Europe, and Japan, there is a specified limit for particles in the final parenteral formulation. Moreover, these pharmacopeia specify two methods for measurement – light obscuration (LO) and microscopic particle count (MPC).
At West, we are by the side of our team members - supporting your training and development needs, providing opportunities to advance in your career and reach your full potential, while maintaining your well-being and work-life balance. In our Team Member Spotlight, learn more about what it is like to work at West and hear about the experiences and careers of some of our team members around the world.
Part 1 of this two part blog series, gave a high-level overview of the new ICH guideline <em>Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management</em>. In part 2 of this blog series, some of the key takeaways will be discussed in more detail. <em>Q12</em> is intended to help companies demonstrate increased product and process knowledge, and understand which post-approval changes will require a regulatory submission, as well as the level of reporting for each category.
A new regulatory guidance in the US has clarified expectations for pharmaceutical companies wishing to transition from an existing pharmaceutical component wash process to another, such as the Westar<sup>®</sup> Ready-to-Sterilize (RS) process.
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