The Global Harmonization Task Force (GHTF) released a new guidance Feb. 5 designed to help manufacturers do a better job with the often fraught task of ensuring supplier quality. "Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained From Suppliers" advises companies to control and audit "sub-tier" suppliers when necessary, noting that firms may need to "extend control beyond the first-tier supplier due to the effects changes made by a second- or third-tier supplier may have on the supplied product/part or the medical device." The document also instructs companies to consider various risks - such as the complexity and criticality of supplied components - when selecting a vendor. Further, "information about potential suppliers (such as technical, financial, continuity of supply, etc.) should be used to determine additional potential risks." FDA GMP/quality systems expert Kim Trautman says FDA intends eventually to adopt the GHTF document as an agency guidance to help industry better carry out Quality System Regulation requirements related to supplier control ("The Silver Sheet" May 2008). The GHTF document can be found at www.ghtf.org/documents/sg3/sg3final-N17.pdf
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