Spectrum Chemicals & Laboratory Products announced it is fully committed to ensuring that every one of their products that contains, or is produced, using one of the pharmaceutical components identified by the U.S. FDA Center for Veterinary Medicine (CVM), a part of FDA's Center for Drug Evaluation and Research (CDER), is free from melamine contamination. Spectrum has developed a proactive approach to the prevention of melamine contamination by documenting the source of all raw materials utilized in the manufacturing process, the assessment of the manufacturing process itself, and the evaluation of other potential sources of melamine contamination of such at-risk products.
Gardena, CA (PRWEB) October 27, 2009 -- Spectrum Chemicals & Laboratory Products (www.SpectrumChemical.com) has re-affirmed their full commitment in ensuring that all the pharmaceutical components they provide are wholesome and contaminant free. In August 2009, the U.S. FDA Center for Veterinary Medicine (CVM), a part of FDA's Center for Drug Evaluation and Research (CDER), published a Guidance for Industry, titled, Pharmaceutical Components at Risk for Melamine Contamination.
Building upon the CVM Guidance, Spectrum has developed its own proactive approach to the prevention of melamine contamination. This approach begins with assuring the integrity of their starting materials. Spectrum has been diligently working with their manufacturing partners and suppliers to address this concern and to extend their melamine-specific quality assurance measures as far upstream as possible in the supply chain. They have been able to do this by documenting the source of all raw materials utilized in the manufacturing process, the assessment of the manufacturing process itself, and the evaluation of other potential sources of melamine contamination of such at-risk products.
Additional tests are being developed by Spectrum's quality control laboratories to provide further assurance that Spectrum products remain free from melamine contamination.
To help their customers formally document the integrity of the materials obtained from Spectrum, product-specific Melamine Certificates that can easily be obtained on the Spectrum website (www.SpectrumChemical.com). "Spectrum remains steadfast in our resolve to safeguard our customers, and the downstream public, from melamine contamination and will continue to offer additional melamine certifications as they become available", says Tom Tyner, Spectrum's VP Quality Control.
About Spectrum Chemicals & Laboratory Products:
Founded in 1971, Spectrum Chemicals & Laboratory Products manufactures and distributes fine chemicals and laboratory products with quality and delivery you can count on every time. Our chemical offerings consist of over 15,000 active pharmaceutical ingredients (API's), excipients, biochemicals, nutraceuticals, cosmetic ingredients, analytical reagents, and chemical solutions in research and production quantities. Spectrum also distributes nearly 80,000 supply and equipment items from over 200 manufacturers like Mettler-Toledo, Ohaus, Corning, Denver Instrument, Hirschmann, Jencons, Microflex, Dyn-A-Med, Thermo Scientific, Wheaton, Kimble Chase, Health Engineering Systems, SPEX CertiPrep, and LabChem. Spectrum's ISO 9001 certified facilities are FDA registered and operate under current Good Manufacturing Practices (cGMP). To learn more about Spectrum visit www.SpectrumChemical.com.
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