Evonik Technochemie GmbH JA – 814
This is Rx-360 Audit Report contains the following scope:
The scope of the audit includes the manufacture, packaging and testing of the following:
Lormetazepam (API) and 4-Carboxy-butyl-triphenyl-phosphonium bromide (Basic
Chemical/Raw Material). Security aspects were also reviewed. The audit was based on Rx-
360 Consortium guidelines for Rx-360 Audit Standards for Active Pharmaceutical Ingredients
and API Intermediates_v2.0. These guidelines are detailed enough to ensure excipient /basic
raw material requirements are also covered.