Safc Quality Audit Services

  • Uploaded by: SAFC-Global
  • 0
  • 0
  • April 2020
  • PDF

This document was uploaded by user and they confirmed that they have the permission to share it. If you are author or own the copyright of this book, please report to us by using this DMCA report form. Report DMCA


Overview

Download & View Safc Quality Audit Services as PDF for free.

More details

  • Words: 782
  • Pages: 3
FORWARD INQUIRIES TO: SAFC Delphine Caraguel Sr. Marketing Communications Coordinator +1.314.286.7911 MEDIA INQUIRIES TO: Mark Button Impress Public Relations + 1.408.310.2168 [email protected]

SAFC® UNDERLINES COMMITMENT TO PHARMACEUTICAL SUPPLY CHAIN QUALITY WITH NEW GLOBAL VENDOR AUDIT SERVICES New vendor auditing program designed to extend audit reach for customers that need to secure global supply chain integrity St. Louis, MO - March 19, 2009 – SAFC®, a member of the Sigma-Aldrich Group (NASDAQ: SIAL), today announced details of its new 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’s Vendor Audit Services are designed to increase customer confidence through the identification of supply chain process improvements and control for purchased raw materials. The program also aims to reduce the cost and personnel impact customers often experience when conducting international vendor audits. Detailed information on the auditing program is available at www.safcglobal.com/auditservices.

SAFC’s Vendor Audit Services serve as an extension to in-house auditing programs 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

(more)

Page 2

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 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.”

SAFC performs hundreds of internal, vendor and customer audits per year. The new Vendor Audit Services enhances SAFC’s leadership position in regulatory compliance and quality assurance and complements existing quality initiatives. These initiatives include 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 program, which provides compliance expertise and guidance around the European Union’s REACH directive.

Further information on SAFC’s Vendor Audit Services can be found at www.safcglobal.com/auditservices About SAFC: SAFC® is the custom manufacturing and services group within Sigma-Aldrich that focuses on high-purity inorganics for high technology applications, cell culture products and services for biopharmaceutical manufacturing, biochemical production and the manufacturing of complex, multi-step organic synthesis of APIs and key intermediates. SAFC has manufacturing facilities around the world dedicated to providing manufacturing services for companies requiring a reliable partner to produce their custom manufactured materials. SAFC has four focus areas – SAFC Pharma® SAFC Supply Solutions®, SAFC Biosciences™, and SAFC Hitech™ – and had annual sales of $624 million in 2008. SAFC is one of the world’s 10 largest fine chemical businesses. For more information about SAFC, visit www.safcglobal.com.

(more)

Page 3 About Sigma-Aldrich: Sigma-Aldrich is a leading Life Science and High Technology company. Its chemical and biochemical products and kits are used in scientific research, including genomic and proteomic research, biotechnology, pharmaceutical development and as key components in pharmaceutical, diagnostic and other high technology manufacturing. The Company has customers in life

science companies, university and government institutions, hospitals, and in industry. Over one million scientists and technologists use its products. Sigma-Aldrich operates in 37 countries and has 7,900 employees providing excellent service worldwide. Sigma-Aldrich is committed to Accelerating Customer Success through Innovation and Leadership in Life Science, High Technology and Service. For more information about Sigma-Aldrich, please visit its award-winning Web site at http://www.sigma-aldrich.com. Cautionary Statement: This release contains forward-looking statements relating to future performance, goals, strategic actions and initiatives and similar intentions and beliefs and other statements regarding the Company’s expectations, goals, beliefs, intentions and the like, which involve assumptions regarding the Company’s operations and conditions in the markets the Company serves. The Company does not undertake any obligation to update these forward-looking statements. ®

®

®

SAFC , SAFC Supply Solutions and Sigma-Aldrich are registered trademarks and SAFC Pharma®, SAFC Biosciences™ and SAFC Hitech™ are trademarks of Sigma-Aldrich Biotechnology L.P. and Sigma-Aldrich Co.

###

Related Documents