Rx-360 begins audit sharing to raise ingredient quality
In July Rx-360 completed an audit sharing pilot programme which it believes showed enough benefits to support wider adoption. Rx-360 members now have access to a database of supplier audit reports.
“Sharing audit reports enables pharmaceutical manufacturers to increase immediately their knowledge of raw material quality and level of regulatory compliance”, Najib Sehat, head of MM-PP regulatory and technical services at Merck Millipore, said.
From the pilot programme Rx-360 identified three main advantages: a broader picture of quality culture; the ability to pre-screen new suppliers; and potential savings from streamlining audits.
Audit reports and associated responses from suppliers are uploaded onto a database for access by other Rx-360 members. Information about the company that conducted the audit is redacted from the report and suppliers can dictate who can view the document.
Suppliers keep the right to keep reports private if they disagree with the findings, or for any other reason, but Rx-360 wants all documents to be shared to give a complete picture of the audit history.
Supplier benefits
Overtime suppliers could benefit from sharing. “The long term benefit is a potential reduction in repetitive audits which in turn allows resources to be focused on continuous improvement efforts”, Andy Polywacz, vice president of quality, Americas at West Pharmaceutical Services, said.
Cutting the frequency or length of audits, and in turn reducing preparatory paperwork, would be beneficial for suppliers. For manufacturers sharing audits should improve understanding of suppliers of interest.
Rx-360 now lists 24 pharmaceutical manufacturers and a similar number of suppliers as members. Trade groups and other bodies are accepted by Rx-360 as observers and the group has seven auditors and 11 associations.
