Supplier control draft guidance delayed
This article was originally published in The Silver Sheet
Executive Summary
The release of a Global Harmonization Task Force (GHTF) draft guidance on outsourcing and supplier controls has been pushed back to March at the earliest, FDA GMP/quality systems expert Kim Trautman says ("The Silver Sheet" May 2007). The document, which will encourage the concept of a "closed-loop" system that places an emphasis on corrective and preventive action (CAPA), is "going to be generic to a supplier of any product or service," says Trautman, who is a part of Study Group 3, the GHTF workgroup developing the guidance. "So it's not going to explicitly call out any particular services or any particular products. Anybody who provides a product or a service will need to go through this assessment and these controls.
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