Tom Beil, VP of Quality and Regulatory Affairs at Sigma-Aldrich and SAFC announced that Sigma-Aldrich successfully completed their fourth global facility audit. He shared this experience in a recent Rx-360 newsletter:
“I am excited to share with the Rx-360 membership and potential members that Sigma-Aldrich just hosted the 4th sponsored audit of one of our facilities as part of a pilot program for a US and European facility.
The audit process and scope has been refined and improved since the pilot phase. The auditors were professional, knowledgeable and thorough. Sponsored by 4 members, the audit carries potential for many more manufacturing members to leverage the audit report through the Rx-360 licensing process. The time-savings of consolidating the audits and avoiding redundancy has more than covered the cost of membership. We are currently aligning the scheduled audits of more of our facilities and our vendors in plans for the 2014-2015 Rx-360 audit schedule.”
Rx-360 was formed in 2009 to support an industry-wide commitment to ensuring patient safety by enhancing quality and authenticity throughout the supply chain. The mission of the organization is timely in light of growing attacks and threats to an increasingly complex and global supply chain. Millions of people around the world are treated every day with the vital medicines that pharmaceutical and biotechnology companies provide.
Management of the pharmaceutical supply chain has become one of the top public health concerns with respect to consumer safety. The globalization of distribution for both drug components and finished products has introduced many complications that Rx-360 is positioned to help resolve.
To learn more about Rx-360, go to the website at www.Rx-360.org.
To listen to a webcast where Tom joins industry colleagues to address regulatory demands and supply chain security, click here (registration needed for first time users).
To learn more about how SAFC is working to provide greater supply chain security and transparency, please click here.