Rx-360 Launches Audit Sharing Program

Rx-360 Launches Audit Sharing Program

The Board of Directors of Rx-360 announced today that the organization has launched it Audit Sharing Program - the collection and sharing of reports from audits conducted by individual member companies on their suppliers. The Audit Sharing pilot program was completed in July 2011, and demonstrated many benefits including:


  • Shared audits provide a broader "picture" of Quality Culture and performance
  • Existing reports can be used to identify and pre-screen new suppliers
  • Potential savings with evaluation of reports/responses to reduce supplier audit frequency/length, or audit scope

In the Audit Sharing Program, Rx-360 member audit reports (and associated audit responses from the suppliers) can be uploaded into a secure database with agreement from the supplier.  The audit reports/responses can then be accessed by other interested companies (as agreed to with the supplier).  This sharing of information can provide pharmaceutical manufacturers with on-going information about specific suppliers of interest, while providing suppliers with visibility to potential customers and the possibility, over time, of reduced pre-audit paperwork, and frequency and/or length of audits.  


"Sharing audit reports enables pharmaceutical manufacturers to increase immediately their knowledge of raw material quality and level of regulatory compliance, and it will improve the visibility of suppliers to other potential companies (customers). This is a jump start to transparency for the entire organization and will bring immense gain in knowledge for stakeholders," said Najib Sehat, Head of MM-PP Regulatory & Technical Services, Merck Millipore Division.

Andy Polywacz, Vice President of Quality, Americas, West Pharmaceutical Services, noted that "There is great short and long term benefit to suppliers participating in the RX-360 Audit Sharing program.  Some of the benefits are a consistency in the audits and the information to be communicated and shared across the Pharmaceutical manufacturers from a supplier standpoint.  The long term benefit is a potential reduction in repetitive audits which in turn allows resources to be focused on continuous improvement efforts.  This is a positive interaction between suppliers and the pharmaceutical manufacturers to improve the sharing of information and in turn improve the robustness of the supply chain."

The pharmaceutical supply chain is a complex endeavor, and Rx-360 expects this to be a significant step in partnering with suppliers to ensure drug product quality in a global environment.
The Audit Sharing Working Group thanks the Board of Directors for their ongoing support of this important initiative. For more information, contact Rx-360 at [email protected]

To learn more about the program click here

About Rx-360:
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 new 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 Rx-360 website at www.Rx-360.org.