SAFC launches global Vendor Audit Services
SAFC, a member of the Sigma-Aldrich Group, is introducing Vendor Audit Services aimed at customers that need enhanced traceability and quality confirmation for critical raw materials and key intermediates destined for their manufacturing processes.
SAFC, a member of the Sigma-Aldrich Group, is introducing Vendor Audit Services aimed at customers that need enhanced traceability and quality confirmation for critical raw materials and key intermediates destined for their manufacturing processes.
The new services are designed to increase customer confidence through the identification of supply chain process improvements and control for purchased raw materials. The programme also aims to reduce the cost and personnel impact of conducting international vendor audits.
SAFC's Vendor Audit Services serve as an extension to in-house auditing programmes and provide pharmaceutical and biotechnology firms with a team of highly trained auditors that have extensive 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.
Standard audits typically include reviews for quality systems, process and product quality, and meet a variety of regulatory standards including but not limited to ISO 9001:2008 (previously ISO 9001:2000), ISO 13485:2003, 21 CFR 211, 21 CFR 820, ICH Q7A, GAMP 5, GLP and 21CFR58 compliance requirements. SAFC can also perform custom audits to suit individual customer specifications.
"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 programme 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."
SAFC performs hundreds of internal, vendor and customer audits per year. The new Vendor Audit Services complement existing quality initiatives, including the Enhanced Quality Profile (EQP), which is designed to help customers identify the proper level of quality for commonly used raw materials, and the REACH regulatory programme, which provides compliance expertise and guidance around the EU's REACH directive.