Ora Laboratory Manual - Fda Office Of Regulatory Affairs Page 14
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Analyst records “NONE” or “NO RESERVE” on the Analyst Worksheet or
electronic form, Item 11, Reserve Sample, and, if applicable, documents the
sample disposition in the FACTS or LIMS “In-House Disposition” record.
•
If a sample is received with an official seal, and no reserve portion remains, the
analyst must include the broken official seal in the worksheet package or
electronic form.
Conditions where no reserve sample remains are usually confined to no action indicated
(NAI) import and NAI perishable samples where the supervisor has concurred in
immediate destruction.
If the entire FDA portion of the sample has been used in the analysis, an analyst may be
instructed by a supervisor to return the empty container(s) under an official seal to the
Sample Custodian for possible use in court.
2.7 Returning Samples to Custodial Storage
The laboratory reserve sample is kept until all legal or other action requiring the sample
is closed. The reserve sample consists of the remaining FDA portion, and, if applicable,
exhibits and the 702(b) claimant’s portion.
Upon completion of the analysis, the Analyst returns any remaining sample reserve to the
Sample Custodian for storage, unless the reserve needs storage conditions not under the
control of the Sample Custodian. (e.g. storage in the laboratory).
2.7.1 Returning Samples to the Sample Custodian
For those samples returned to the Sample Custodian, the sample custodian and the analyst
document the transfer of the sample in FACTS or LIMS.
The Sample Custodian verifies that the physical sample received matches that described
in the FACTS or LIMS “Sample Transfer” record. Any discrepancies (e.g. quantity, unit)
between the physical sample and the sample description in the “Sample Transfer” record
are immediately reported to the analyst. Discrepancies are reconciled and, if needed, the
FACTS or LIMS record is corrected. The Sample Custodian updates the sample storage
location in the FACTS or LIMS “Sample Transfer” record.
2.7.2 Returning Samples to Storage Areas not Controlled by the
Sample Custodian
ORA Lab Manual, Volume III, Section 2 – Chain of Custody-Sample Handling
Page 14 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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