Ora Laboratory Manual - Fda Office Of Regulatory Affairs Page 19
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21sample disposition must contact the laboratory management if there is any question to the
method.
Destruction or other authorized disposition is the last step in accountability for the
physical sample. FACTS or LIMS documents sample destruction; only the Sample
Custodian, or those designated with this role within FACTS or LIMS, may complete and
document the disposition of the sample.
2.9.2 In-House Disposition of Reserve Samples
In certain instances, the Analyst may destroy the Reserve Sample prior to receiving
official notification authorizing sample disposition. Conditions where no Reserve Sample
remains are usually confined to NAI import and NAI perishable samples where the
laboratory supervisor has concurred in immediate destruction. The Analyst documents
the In-House destruction in the FACTS “In-House Sample Disposition” record or in the
LIMS record.
With the approval of the Laboratory or Compliance Branch Director, the Reserve Sample
may be used for FDA purposes rather than destroyed (e.g., research, working standard,
exhibit). In these instances, sample numbers are removed or obliterated to avoid potential
confusion with samples that are in-progress.
2.10 References
• U.S. Food & Drug Administration, Office of Regulatory Affairs,
Investigations operations manual or the website address,
• U.S. Food & Drug Administration, Office of Regulatory Affairs, ORA
laboratory manual or the website address,
• FACTS Manuals
• LIMS User’s Manual
• Sample Receipt Central Receiving
• Sample Receipt in Lab
• Inventory Management
ORA Lab Manual, Volume III, Section 2 – Chain of Custody-Sample Handling
Page 19 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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