Chain of Custody Form

Laboratory Operations (Part J) cGMP SOP Templates and Supporting Documents

Chain of Custody Form

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Published: Thursday, April 1, 2010

This is an example of a Chain of Custody form that can be used to document the transfer of a sample from the company to an outside laboratory for testing. While not explicitly required by dietary supplement GMPs, this documentation is considered essential to ensure the integrity of analytical results. FDA will generally not accept test results from a sample which was not accompanied by a proper Chain of Custody. (This comes up, for example, when FDA requires proof that a shipment offered for import is free of a particular contaminant.) The form may be modified to include a Purchase Order number, entry number (for imports), sample collection information (where not documented separately), or other relevant information. Upon receipt of the sample, the outside laboratory’s sample manager will sign the bottom of the form. A copy of the completed form should be provided with the final analytical results.
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