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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 at PharmaLink 2015. 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!