Blogs

Trend #1 – Particulate, particulate, particulate

This industry buzzword of the last few years is not going anywhere in 2015. Particulate reduction will continue to be the area of focus for all container closure systems, including the traditional vial/stopper/seal combination. For glass and elastomer manufacturers, the emphasis will be on reducing foreign material in the manufacturing process through enhanced gowning and environmental controls, elimination of sources of cellulose, equipment maintenance, and placing increased pressure on their raw material suppliers. Pharmaceutical companies will need to evaluate if older components will meet the modern particulate requirements of the market.

Part 4 of the Good Supply Practices Series

West is pleased to welcome guest blogger Dr. Marla Phillips, Director, Xavier Health, Xavier University. This is the fourth installment in a four-part series on supply chain management.

There is strong recognition that human factors play a large role in how the supply chain operates (as with everything else).  Success and positive impact cannot be attained without simultaneously addressing what drives human behavior in this space. 

Part 3 of the Good Supply Practices Series

West is pleased to welcome guest blogger Dr. Marla Phillips, Director, Xavier University. This is the third installment in a four-part series on supply chain management.

At the outset of the Integrity of Supply Initiative, an assumption was that suppliers cannot consistently supply what is needed.  However, it was discovered through our research that manufacturers often do not know what specifications are actually needed, do not involve suppliers in development discussions, do not explore the full expertise of suppliers, do not understand their own process well enough to know how the incoming material will impact their process, and do not ask for the process capability of their suppliers.

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).

In a recent Flash Report, Rx-360.org offered a summary of the proposed USP Chapter 1083 – Good Distribution Practices – Supply Chain Integrity.  In its report, Rx-360 noted that “globalization of all aspects of the pharmaceutical business has driven the need to address the threats of counterfeit or adulterated medication, devices and components, for which there have been several high-profile examples over the last few years.”