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Part 2 of the Good Supply Practices Series West is pleased to welcome guest blogger Dr. Marla Phillips, Director, Xavier University. This is the second installment in a four-part series on supply chain management. In my previous blog, I mentioned the three overarching themes that need to be addressed to help ensure the integrity of the materials supplied throughout the pharmaceutical and medical device supply chains through the development of Good Supply Practices (GSPs).
Many manufacturers have supplier selection and supplier approval processes in place, yet demands on speed to market often result in circumvention of these processes. Additionally, it has been found that supply agreements often conflict with the requirements of other agreements (such as Quality Agreements) and drive the wrong behavior, as it is difficult to satisfy both sets of expectations.
It’s not hard to imagine that if industry agreed upon some key supply chain practices to harmonize on, that suppliers would be able to focus resources on more critical aspects of supply reliability than managing more than one-hundred different ways to perform the same task.
The contribution to the GSPs related to this theme will address the topic of transparency in conjunction with trust, forecasting ability related to stability, and the standardization of several practices – including internal alignment processes and risk considerations versus need.
The supplier relationship must be maintained throughout the product lifecycle, which often requires different decisions to be made at different points in time. The exploration of which functional groups to involve and when will be added to the GSPs for companies to consider in their processes.
Financial aspects as well as quality, safety and brand will be addressed, as well as lack of leverage and risk factors (internal and external) that need to be explored.
In my next blog, I’ll discuss the product and Process Knowledge and Development theme. In the meantime, if you’d like to learn more about the Integrity of Supply Initiative, join me. The conference, co-sponsored by the FDA and Xavier University, will be held on Xavier University’s campus March 24-27, 2015.
You’ll learn more about the initiative, identify solutions that will protect patients around the world and work through real working models that can improve the reliability of your product.
See you there!
In May of 2015, Exton announced their West Without Borders focus on the Year of the Veteran, with The Travis Manion Foundation named as one of the recipient charities.
Cartridge-based administration using injection device systems has dominated the insulin market for many years. In 2011, the insulin market for cartridge-based container closure systems was at an estimated 1 billion units. Additional applications for cartridge-based container systems include dental, at more than 450 million units per year, and therapies such as human growth hormone, interferon and epinephrine. In fact, thanks to lower production costs when compared to vial and syringe systems, cartridge-based delivery has found a widespread and growing market.
Since the 2012 New England Compounding Center tragedy that linked a deadly fungal meningitis outbreak to a failure to use current good manufacturing practices (cGMP),<sup>1</sup> compounding pharmacies have faced increasing scrutiny and regulation by the U.S. Food and Drug Administration (FDA). While registering with the FDA is still voluntary, only compounding pharmacies that register, and pass inspection, will be granted “503B” status as compounding outsourcing facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act.<sup>2</sup>
When choosing an elastomeric formulation for a stopper or plunger used to package parenteral drug products, there are several misconceptions related to the importance the elastomer class plays on the chemical and physical properties of the elastomer. Often we hear customers make general statements such as “chlorobutyl elastomers are better” or “bromobutyls have an advantage in property X.” In actuality, each elastomeric formulation is unique and has different properties that are independent of the class of elastomer.
On 9 November 2017, West officially opened our recently expanded Kiefernweg Campus in Eschweiler, Germany, which includes a new global center of excellence for the research and development of pharmaceutical packaging components and systems for injectable medicines.
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