Rx-360 publishes audit standards
The Rx-360 consortium has published audit standards for active pharmaceutical ingredients (APIs) and API intermediates and 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-3
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