Ora Laboratory Manual - Fda Office Of Regulatory Affairs Page 15
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21Special storage may call for all or a portion of the sample or exhibits to be stored in areas
not controlled by the Sample Custodian (e.g. the laboratory). If the reserve sample is not
returned to the Sample Custodian, the following documentation is recorded on the
Analyst Worksheet or electronic form, Block 11, Reserve Sample:
•
location and environmental conditions where the reserve is stored;
•
an explanation why the sample was not returned to the Sample Custodian for
storage; and,
•
amount of sample stored.
2.8 Shipping Samples from the Laboratory
Samples or portions of samples thereof are shipped from the FDA/ORA laboratory
facility by various means. All shipment information is documented by the Sample
Custodian or their designee in FACTS or LIMS.
The individual circumstance will dictate whether the entire sample or only a portion of
the sample is shipped. The Sample Custodian is generally responsible for shipment of
samples to other facilities. He or she assures that the sample is packaged in a manner that
maintains its integrity. If the Sample Custodian is uncertain how a sample should be
packaged for shipment, a supervisor or analyst is consulted.
When a 702(b) portion of a sample is to be shipped to a claimant, an FDA portion
shipped to another laboratory, or a complaint sample is returned to the consumer, the
Sample Custodian proceeds only with electronic or written authorization from laboratory
management.
Samples are shipped from the FDA/ORA laboratory facility by various means, (e.g.
FedEx®, UPS®, Airborne®, FDA personnel, or personal deliveries such as the Sample
Custodian to the local police).
2.8.1 Shipping the Entire Sample
Preparation and shipment of the entire sample 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 an analyst.
2.8.1.1 Sample is Stored in the Custodial Storage Area
ORA Lab Manual, Volume III, Section 2 – Chain of Custody-Sample Handling
Page 15 of 21
This document is uncontrolled when printed: 6/4/2014
For the most current and official copy, check the Internet at
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