Ora Laboratory Manual - Fda Office Of Regulatory Affairs Page 16
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21If the sample to be shipped is in the sample storage area, the Sample Custodian retrieves
the sample from the storage area, packs the sample for shipment, and ships the sample
following the laboratory’s local SOP or work instruction(s) for shipping samples.
2.8.1.2 Sample is in the Custody of the Analyst
If the sample to be shipped is in the custody of the analyst, the analyst prepares the
sample for shipment.
The analyst returns 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 for shipment, and ships the sample following the
laboratory’s local SOP or work instruction(s) for shipping samples. The Sample
Custodian ships the sample in accordance with carrier and federal regulations, i.e.,
dangerous goods, infectious substances, hazardous materials..
2.8.2 Shipping a Portion of the Sample
For the preparation and shipping of a portion of the sample to a claimant or another
laboratory, an analyst prepares the portion for shipment. Preparation and shipment of the
portion depends upon whether the sample:
•
is stored in the sample storage area under the custody of a Sample Custodian, or,
•
is in the custody of the analyst.
2.8.2.1 Samples Stored in the Custodial Storage Area
Samples that are stored in the sample storage area are obtained by the analyst from
custodial storage following procedures described in Section 2.4 Receiving Samples from
Custodial Storage and Opening the Sample Package. If the sample had previously been
analyzed by the laboratory, the analyst whose name appears on the seals(s) of the Reserve
Sample (if applicable) obtains the sample, prepares, and seals the portion for shipment.
After receiving custody of the sample, the analyst breaks the official seal and opens the
sample package following the procedure described in Section 2.4 Receiving Samples
from Custodial Storage and Opening the Sample Package. The analyst splits the sample
into portion(s) and documents the split by following the procedure described in Section
2.5 Intra/Inter Laboratory Splitting and Transferring of Samples. Additionally, the analyst
documents the process of breaking seals, preparing samples, and describing the reserve
sample on a new Analyst Worksheet. The worksheet is processed through normal
channels to become an addition to the original worksheet.
ORA Lab Manual, Volume III, Section 2 – Chain of Custody-Sample Handling
Page 16 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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