The single-use audit guide has been designed to help the auditor and auditee understand the areas of focus in SUS audits, referencing relevant requirements and SUS manufacturing ‘elements’. It is also designed to assist the auditor in reporting their assessment of SUS manufacturers to the end-user. It includes sections on general quality management system areas and products and production processes to consider. It is designed to be applicable to audits of single-use system manufacturers.
Viewing related articles
Over the course of 14 months, eight site audits were carried out on BioPhorum’s Supply Partner supplier member company sites and these were made available for industry to license via the Rx-360 website. The audits were conducted through the Rx-360 Joint Audit Program and its audit partner BSI. This report details the methodology of the approach, the feedback and the findings of all the stakeholder groups involved and the reviewer panel involved in the pilot program.