July 10, 2014

Integrity of Supply Initiative Develops Industry-Wide Good Supply Practices

Integrity of Supply Initiative  Develops Industry-Wide Good Supply Practices

Cincinnati, OH – Pharmaceutical and medical device professionals, as well as their supplier partners visited the Xavier University campus for two days in May to roll-up their sleeves on the Integrity of Supply Initiative. The goal of the initiative is to develop and implement pragmatic Good Supply Practices (GSPs) that increase the reliability of incoming supply across the pharmaceutical and medical device industries. A more reliable supply chain reduces risk to finished product quality and patient safety, which in turn leads to business success.  The members of the group agree that one of the aims of the initiative is to determine the source of dysfunction affecting the Integrity of Supply in these regulated industries. By finding the sources of dysfunction the group is able to implement sustainable solutions that can be tied to return on investment.  Some of the benefits will include increased safety, improved quality and enhanced reliability.

More than twenty of the most well-known companies in these industries sent high level Quality and Supply Chain experts to the two day meeting. Some of the companies represented include:  Eli Lilly, Baxter, Merck, Procter & Gamble, Boston Scientific, and Johnson & Johnson.  Each company was personally invited by the representatives of Xavier Health because of their global standing and proven track records of patient and business success.  When the group, including FDA officials from the Office of the Commissioner, first met in August 2012 they believed the suppliers were causing problems with the integrity and reliability of the supply chain.   The result of root cause exercises, surveys, interviews and focus group sessions pointed toward a major paradigm shift in these Industries that every area of dysfunction related to the reliability of incoming supply is caused by and/or can be controlled by the manufacturers themselves, not their suppliers. This paradigm shift gave the Integrity of Supply Initiative the direction necessary to begin developing solutions to address supply chain issues. Membership of the initiative has been broadened to gain insight through formal involvement of suppliers in solution development.

During the May 2014 meeting the group was divided into three working groups to address dysfunction related to:  (1) incomplete product and process knowledge and development, (2) insufficient supply chain development and management, and (3) inadequate behavior and communication. Each working group brought new ideas to the initiative while folding in historical data to create problem statements relevant to the scope of their group. “We asked everyone to present opportunities for improvement by thinking about what they would do if they were king/queen for a day” said Marla Phillips, Director of Xavier Health. The working groups then prioritized all input, which they will later develop into GSPs. They also created team charters which require them to meet and report their progress on a regular basis.  Each working group plans to apply solutions across product development stages, address legacy products and provide options, decision making tools and best practices throughout the industry.

FDA officials have been deeply involved during the discovery phase of the initiative, and are now serving in an advisory role to the leadership of the initiative.  Dates have been set for follow-up meetings over the next twelve months and the group will announce future plans for sharing the information at a later date.