Audit Report

Xellia Pharmaceuticals Ltd JA – 894

Audit #: JA - 894
Region: Germany
Material: API/Excipients
Company: Xellia Pharmaceuticals Ltd
Location: Szallas utca 3 Budapest Hungary
Date: 28-29 November 2017

Rx-360 Audit Report contains the following scope:

The scope of this audit was to assess manufacturing, packaging, distribution and support
functions for API Gramicidin at the Budapest, Hungary site using the RX 360 Audit Standard
for Active Pharmaceutical Ingredients and API Intermediates v.1.0. Document Number:
2460627 and the Supply Chain Security Checklist v.2.0 Document Number: 2790748.
The above listed Rx 360 guidelines are relative to ICHQ7 and for the Supply Chain Security
the following apply:
 Customs-Trade Partnership Against Terrorism (CTPAT)
 U.S. Customs and Border Protection
 U.S. Department of Homeland Security
 21 CFR 210/211
 The International Pharmaceutical Excipients Council (IPEC)/Good Distribution
Practices Guideline for Pharmaceutical Excipients
 World Health Organization (WHO) Good Distribution Practices