Audit Report

Evonik Technochemie GmbH JA – 814

Audit #: JA - 814
Region: Germany
Material: API/Excipients
Company: Evonik Technochemie GmbH
Location: GutenbergstraBe 2 Dossenheim 69221
Date: 7-8 February 2017

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.