Single-use system audit guide

The single-use audit guide was created as part of a collaboration between BioPhorum and Rx-360®. The guide has been designed to help the auditor and auditee understand the areas of focus in single-use systems (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.

This guide provides guidance for purchasers and suppliers of SUS, built on the experience of industry subject-matter experts from across the collaborative community of BioPhorum and the wider industry.

This guide can assist an auditor to perform a robust audit of SUS areas. The ISO standards used for this guide are:

• ISO 9001: 2015 Quality Management Systems Requirements
• ISO 14644-2: 2015 Cleanrooms and Associated Controlled Environments.

The guidelines chosen exclude ISO 13485 Medical Devices as SUS are not considered medical devices. While many suppliers are ISO 13485 certified, the focus of the BioPhorum SUAG is to ensure auditees are compliant with Quality Management Systems and related cleanroom standards. Supplier certification to ISO 13485 will be captured in the audit reports, but is not a requirement.

An audit is an assessment of an auditee’s compliance to applicable standards. This guide provides the requirements against which a manufacturer should comply (as applicable). This guide contains product-specific manufacturing elements that are unique to each SUS product type. These are not regulations, and observations should not be cited to them directly. However, these elements may be part of the SUS manufacturing processes, and manufacturer management and control of these elements would fall under these manufacturing processes.