We recognize that to mitigate risk and meet increasing regulatory guidelines for commercial manufacturing, our customers need a highly reliable supply chain, access to documentation, and a collaborative approach to understanding and addressing their unique compliance requirements.
As a fully integrated manufacturer for our specialty chemistries, ANGUS is uniquely positioned to offer a 100% traceable supply chain, with a clear line of sight back to raw materials – all of which are produced on-site to stringent specifications. Together with our single Global Quality Management System, this means absolute confidence you can readily qualify material and have a secure, sustainable supply. In addition, our products are properly certified as meeting quality and compliance standards in accordance with the strictest requirements of the industry’s leading certification bodies.
Standard Product Qualification Documents
Standard Product Qualification Documents
- Safety Data Sheets (SDS)
- Product Sales Specifications
- Certificate of Analysis (CoA)
- ISO 9001:2015 Certificate
- High Level Manufacturing Process Flow
- Regulatory Data Sheets*
- Product Stability Data*
- cGMP Statement of Conformance*
- Excipient Information Packages*
- Precedence of Product Use*
*Available for select products
Certifications
Certifications
ISO 9001
- Sterlington, Louisiana – 01799-2006-AQ-HOU-ANAB
- Ibbenbüren, Germany – 506381-QM15 (English)
- Ibbenbüren, Germany – 506381-QM15 (German)
ISO 50001 Energy Efficiency
Designed to the Highest Standards
Designed to the Highest Standards
Our manufacturing facilities in Sterlington and Ibbenbüren are audit-ready and offer:
- ISO 9001:2015 certification
- Adherence to current IPEC guidelines for cGMP compliant manufacturing of excipients*
- Automated in-process monitoring and facility control system
- In-house testing utilizing validated analytical methods
- Elemental impurity risk assessment using ICP-MS technology*
- Comprehensive validation documentation*
- State-of-the-art filling and packaging suites for Life Sciences products*
*Available for select products