Issued for APIs and intermediates together with two new audit tools
The Rx-360 consortium has published audit standards for active pharmaceutical ingredients (APIs) and API intermediates and two new audit tools, which it says is a significant step in its efforts to secure the pharmaceutical supply chain through shared audits.
The announcement comes a month after the consortium of pharmaceutical and biotechnology companies received approval from the US Federal Trade Commission (FTC) for the Rx-360 Audit programmes.
‘By working together to create and support these standards, Rx-360 members are setting expectations and levelling the playing field in order to protect the patients we all serve,’ said Martin VanTrieste, Rx-360 chairman.
The Rx-360 Audit Standards for Active Pharmaceutical Ingredients (APIs) and API Intermediates are based on ICH Q7 and EMEA/410/01 revision 2. In addition, the standard is formatted as an audit guide and therefore may be used as a tool to perform audits.
The two new audit tools include the Rx-360 Audit Guide for Basic Chemicals and Raw Materials, which is based on the IPEC/PQG Good Manufacturing Practices Audit Guide for Pharmaceutical Excipients (2007). This document applies to all basic chemicals and raw materials used in pharmaceutical manufacture.
The Rx-360 Supply Chain Security Checklist for Auditors serves as a tool for assurance of supply chain security and integrity; it is not a standard. The checklist addresses both physical/facilities security and security related to materials and documentation.
All three documents are now available to download for registered website members at: http://bit.ly/djrQlo