SAFC Announces Enhanced Quality Profile for In Vitro Diagnostics Raw Materials |
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July 17, 2007 |
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St. Louis, MO - July 17, 2007 - SAFC®, a member of the Sigma-Aldrich group (Nasdaq:SIAL), has announced key enhancements to its Quality Assurance Program for raw materials purchased by diagnostics houses and other manufacturers through the SAFC Supply Solutions™ business segment. An Enhanced Quality Profile has been put in place to classify product quality for commonly-used raw materials such as buffers, enzymes and proteins, helping customers identify and be confident in selecting the proper level of quality for the materials they require in their manufacturing programs.
The Enhanced Quality Profile program has been validated through industry-wide acceptance of over 75 buffer products put into the quality classification system over the last 18 months. The program has been extended to include more than sixty enzymes and proteins routinely used by diagnostics manufacturers and others, and will continue its expansion to include additional products in the future.
As part of its customer-focused approach, the SAFC system identifies the level of quality assurance available within the product lifecycle using a multi-level qualification system. The system is designed to provide customers with batch-specific information and covers issues like policies and procedures standardization for internal systems, documented product specifications and analytical methods, (including shelf-life retest data), certificates of origin, quality assurance review, change control notification, lot sample retention, and vendor management and performance evaluation. Upper classifications of the system recognize ISO 9001:2000 requirements plus elements of other international standards such as the International Conference on Harmonization (ICH) and European Directorate for the Quality of Medicines and Health Care (EDQM).
"Understanding our customers' quality needs and strengthening our capabilities to meet or exceed them is the cornerstone of our quality assurance mission", said Bryan Ball, Vice President of Quality and Regulatory Affairs for SAFC. "The Enhanced Quality Profiles for products included in this system are the foundation of an extensive and on-going quality program that provides customers the confidence to know SAFC raw materials are what we say they are, because we have the systems and documentation in place to prove it".
A customized, total supply chain partner for raw materials, SAFC Supply Solutions offers over 100,000 products, including 46,000 manufactured in-house. With biochemical raw materials for pharmaceuticals, biopharmaceuticals, IVD manufacturing and Flavors & Fragrances, the business has production facilities in the U.S., Germany, Switzerland, the U.K. and Ireland.
For more information, visit www.safcsupplysolutions.com.
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 operating segments - SAFC Pharma, SAFC Supply Solutions, SAFC Biosciences, and SAFC Hitech - and had annual sales of nearly $500 million in 2006. SAFC is one of the world's 10 largest fine chemical businesses.
About Sigma-Aldrich:
Sigma-Aldrich Sigma-Aldrich is a leading Life Science and High Technology company. Our biochemical and organic chemical products and kits are used in scientific and genomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as key components in pharmaceutical and other high technology manufacturing. We have customers in life science companies, university and government institutions, hospitals and in industry. Over one million scientists and technologists use our products. Sigma-Aldrich operates in 36 countries and has 7,600 employees providing excellent service worldwide. We are committed to accelerating Customers' success through leadership in Life Science, High Technology and Service. For more information about Sigma-Aldrich, please visit our award-winning web site at 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 Companies' expectations, goals, beliefs, intentions and the like, which involve assumptions regarding the Companies' operations and conditions in the markets the Companies serve. The Companies do not undertake any obligation to update these forward-looking statements.
Forward Inquiries To:
Dr. Frank Wicks
President, SAFC
+ (314).286.8008 |
Media Inquiries:
Mr. Richard Kerns
Northern Exposure
+44.161.728.5880 |
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