Distribution Records required by FDA - 21CFR820.160


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FDA - 21CFR820.160 requires each manufacturer to maintain distribution records within include or refer to the location of:
(1) The name and address of the initial consignee;
(2) The identification and quantity of devices shipped;
(3) The date shipped; and
(4) Any control number(s) used.

Historically, we have included a copy of the waybill from our carriers in the DHR.

The question was raised whether the packing slip from our EBS system would be sufficient since it contains requisite information.

Instead of using the carrier shipping receipt or waybill, are there other acceptable methods of documenting the required information.

I'm very curious to hear how other folks are documenting this information.
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Starting to get Involved
Hi fcowdery,

For our organization, distribution is initiated by the Packaging Slip issued by Sales to our Warehouse which are generated from our ERP system. The Packaging Slip identifies the shipping consignees address (customer), quantity of each part number shipped, the date shipped, and batch (or LOT) number for each part number.

All orders are pulled from stock using the Packing Slip and employees initial each line item off as the part is packaged. Orders are then verified by a second person who then initials each line on the Packing Slip.

Completed Packing Slips become part of the DHR and are retained accordingly.


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