Ora Laboratory Manual - Fda Office Of Regulatory Affairs Page 18
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21The analyst prepares the portions for shipment.The analyst returns the now split portions
of the reserve sample to the Sample Custodian following the procedure described in
Section 2.7 Returning Samples to Custodial Storage.
The Sample Custodian packs the sample portion identified for shipment, and ships the
portion in accordance with carrier and federal regulations, i.e., dangerous goods,
infectious substances, hazardous substances. The Sample Custodian documents shipment
of the sample following the procedures described in Section 2.8.3 Documenting Sample
Shipment.
2.8.3 Documenting the Sample Shipment
The Sample Custodian (or designee) documents the shipment of samples or sample
portions by entering the information into FACTS or LIMS.
2.9 Disposition of Samples
Once all legal action requiring the sample is concluded, the Sample Custodian receives
notification for disposition of the sample. Sample disposition notification is initiated
through FACTS. Additional sample disposition notification may be provided through
written authorization from the laboratory supervision. Upon receipt of the sample
disposition notification, the sample is removed from its place of storage and destroyed
within thirty (30) days.
The Sample Custodian or other personnel as directed by the laboratory management
perform sample destruction. When any portion or the entire reserve sample is stored in a
location other than the custodial storage area, the analyst may be assigned to destroy the
sample.
2.9.1 Sample Destruction
Sample destruction entails destroying and denaturing the entire reserve sample to the
point the material is rendered unusable. The manner of destruction will depend on the
individual sample. Destruction processes that minimally impact the environment are
considered. Methods such as incineration, de-characterization, chemical destruction,
landfill disposal, and autoclaving can be used. Immediate sample containers are empty
when placed in a waste receptacle. Sample destruction is conducted in accordance with
the laboratory hazardous waste management plan, applicable biosafety guidelines, and
general safety precautions.
Controlled drugs (CRx/DEA) regulations require the destruction of CRx/DEA controlled
drugs must be witnessed by a designated Supervisor. The person assigned to perform the
ORA Lab Manual, Volume III, Section 2 – Chain of Custody-Sample Handling
Page 18 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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