Quality Systems Overview

 

Sigma-Aldrich Corporation

SAFC is a member of the Sigma-Aldrich group, a global corporation with sales, manufacturing, and distribution facilities in 35 countries. SAFC focuses on custom-manufacturing and customized raw-material supply services within Sigma-Aldrich. SAFC provides biochemical production; cGMP manufacturing of complex, multi-step organic synthesis APIs and key intermediates and the largest raw material offering with more product references than any other company.

SAFC has multiple manufacturing facilities worldwide that are registered with the FDA and operate under cGMP regulations, dedicated to providing manufacturing services for companies requiring a reliable partner to produce their custom manufactured materials.

SAFC Quality Organization

SAFC Quality Organization
See how SAFC has optimized our Quality Organization to meet your Quality and Regulatory requirements.

Organization
View SAFC's leardership of Quality Management & Regulatory Affairs functions.

Reporting Structures
Find out how SAFC Corporate Quality organizations work together.

Quality Responsibilities
Review the responsibilites of Quality Assurance and Quality Control.

SAFC Quality Systems

Learn how our Quality Systems can be customized to meet your spacific needs.

Quality Records and Batch Documentation
See how our Quality Systems meet stringent regulatory requirements, but are flexible for your customized needs:
     • Product Specs & Cert of Analysis
     • Analytical Test Methods
     • Product Information Sheets
     • Certificate of Origin
     • BSE/TSE Declarations
     • Certificate of Suitability (CofS)
     • Product Labeling
     • Drug Master Files
     • MSDS
     • Technical Resources
     • SAFC Biosciences' Technical Services

Customer Audits
Schedule & visit our facilities and evaluate our many Quality System programs.

Regulatory Affairs
Find out how SAFC provides knowledge of international guidelines and regulations as well as regulatory guidance for you.