SAFC Offers Global Vendor Audit Services

SAFC, a member of the Sigma-Aldrich Group, has announced its new Vendor Audit Services aimed at companies seeking enhanced traceability and quality confirmation for critical raw materials and key intermediates for their manufacturing processes. The company’s Vendor Audit Services are designed to increase customer confidence with supply chain process improvements and control for purchased raw materials. According to the company, the program aims to reduce the cost and personnel impact customers often experience when conducting international vendor audits.

The program provides pharmaceutical and biotechnology firms with a team of trained auditors that have regulatory compliance expertise and are on-the-ground in local regions, including China. This service is expected to enable customers to conduct a greater number of audits across wider geographic regions without the need to expand their regulatory compliance teams, increase their global travel or wait for translations, according to the company. Standard audits typically include reviews for quality systems, process and product quality, and meet a various regulatory standards including: ISO 9001:2008, ISO 13485:2003, 21 CFR 211, 21 CFR 820, ICH Q7A, GAMP 5, GLP and 21CFR58 compliance requirements. The company also performs custom audits.

“SAFC understands that ensuring the proper quality for raw materials that feed customer pipelines is vital to their success, and quality assurance has always been a top priority for SAFC-sourced raw materials,” said SAFC president Gilles Cottier. “This program leverages the high level of trust our customers have in SAFC’s regulatory expertise and pioneers a much needed regulatory compliance service that can benefit our customers by providing them with an efficient and effective method to help them ensure that quality requirements are met for materials internationally sourced.”