Thursday, 14 June 2018

Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry

FDA has issued a new guidance of interest. This guidance is intended to assist trading partners in standardizing the data contained in the product tracing information that trading partners must provide, capture, and maintain…This guidance is also intended to help trading partners understand the data elements  that should be included in the product tracing information, particularly in situations where trading partners are permitted by law to provide other trading partners with product tracing information that omits certain elements that would otherwise be required. In addition, this guidance recommends documentation practices that trading partners can use to satisfy the product tracing requirements.

For details see: FDA

Posted by Dr. Tim Sandle

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