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, Advancion 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.
- 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
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
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