Integrity of Supply Initiative Developing Good Practices

West is pleased to welcome guest blogger Dr. Marla Phillips, Director, Xavier University.

Materials and products used to serve the drug and device industries are supplied from areas all over the world. From raw materials such as sand to highly processed components for delivery systems, the materials that are used to create packaging systems are presumed to be safe.  But how can pharmaceutical manufacturers be sure that incoming materials used in these products are consistently safe and reliable?

Through the Integrity of Supply Initiative, Xavier Health is developing Good Supply Practices (GSPs) for the pharmaceutical and medical device industries to provide solutions to increase the reliability of supply.  Perhaps the greatest discovery revealed through the initiative to date is the paradigm shift that every area of dysfunction related to the reliability of supply is caused by and/or can be controlled by the manufacturers themselves, not their suppliers. It is through this greater understanding that our solutions will shift from increasing supplier controls to improving how manufacturers work with their suppliers.  The solutions will be tied to return on investment, will be commensurate with risk-based need, and will provide cross-industry best practice options.

It is the mission of the Integrity of Supply Chain Initiative to determine the source of the dysfunction affecting the integrity of supply, and to implement sustainable solutions that can be tied to return on investment, including increased safety, improved quality and/or enhanced reliability.

Pharmaceutical manufacturers, and ultimately, the patients they serve – need a reliable and consistent supply chain of safe, quality materials and products to limit adverse impact on the end user.

However, research results generated by manufacturers through the Xavier initiative has revealed that most of the issues begin with dysfunctions caused by the manufacturers themselves.

Areas of identified improvement opportunities fell under three main themes:

• Supply Chain Development and Management
• Product and Process Knowledge and Development
• Driving Ideal Behaviors

Identified by pharmaceutical and medical device manufacturers and corroborated by suppliers, these themes help to identify dysfunction that can be mitigated or avoided through the improvement of internal supply practices and/or through harmonization across the industry.

In future blogs, I’ll address each of these themes and next steps to help ensure greater reliability in our supply.

Interested in learning more?  Then register now for PharmaLink 2015!  The conference, co-sponsored by the FDA and Xavier University, will be held on Xavier University’s campus March 24-27, 2015.  Join us!