Ora Laboratory Manual - Fda Office Of Regulatory Affairs Page 17
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21The analyst prepares the portion(s) for shipment. The analyst returns the portion of the
sample to be shipped to the Sample Custodian following the procedure described in
section 2.7 Returning Samples to Custodial Storage.
The Sample Custodian packs the sample portion for shipment, and ships the portion in
accordance with federal regulations. The Sample Custodian documents shipment of the
sample following the procedures described in Section 2.8.3 Documenting Sample
Shipment.
2.8.2.2 Samples in the Custody of the Analyst
The analyst splits the sample into portions following the procedure described in Section
2.5 Intra/Inter Laboratory Splitting and Transferring of Samples.
If the sample being prepared for shipment is in process, the analyst states the following
on the Analyst Worksheet or web application:
•
sample description, sample provided, and amount;
•
how it was prepared for delivery;
•
sample identification (description of seal, if appropriate);
•
brief explanation as to why the sample was sent;
•
to whom the sample was sent; and,
•
date of shipment.
If the sample being prepared for shipment is a reserve sample that has not been returned
to the Sample Custodian due to special storage (refer to Section 2.7, Returning Samples
to Custodial Storage), a new Analyst Worksheet or LIMS record is initiated to document
the following:
•
the process of breaking seals (if applicable),
•
preparing the sample portions,
•
sample description and amount provided,
•
to whom the sample was sent,
•
how the sample was sent for delivery,
•
short explanation why the sample portion was sent, and
•
description of the reserve sample.
The worksheet is processed through normal channels to become an addition to the
original worksheet or record.
ORA Lab Manual, Volume III, Section 2 – Chain of Custody-Sample Handling
Page 17 of 21
This document is uncontrolled when printed: 6/4/2014
For the most current and official copy, check the Internet at
http://
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