Ora Laboratory Manual - Fda Office Of Regulatory Affairs Page 9
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212.4 Receiving Samples from Custodial Storage and
Opening the Sample Package
2.4.1 Receiving Samples from Custodial Storage
When needed for laboratory use, the Analyst obtains a stored sample from the sample
custodian, and the transfer/change of custody of the sample is documented using FACTS
or LIMS.
The analyst verifies that the physical sample received matches that described in the
Sample Packages section of the FACTS or LIMS “Lab Receipt of Sample” record. Any
observed discrepancies (e.g., package number, condition, seal inscription, seal condition)
are documented using the Laboratory’s Complaint and Corrective Action Procedures.
The analyst verifies that the physical sample received matches that described in the
FACTS or LIMS “Sample Transfer” record. Any discrepancies (e.g., quantity, unit, split
number) between the sample and that described in the FACTS or LIMS “Sample
Transfer” record are immediately reported to the Sample Custodian. Discrepancies are
reconciled and, if needed, the FACTS record is corrected.
If FACTS or LIMS is unavailable, (e.g. computer server is down) at the time of the
sample transfer, the laboratory uses its Computer Contingency Plan in order to document
the sample transfer operations.
2.4.2 Opening the Sample Package
After receiving custody of a sample, the analyst performs the following functions:
•
breaks the Official Seal (if present); and
•
opens the package, and inspects the sample.
2.4.2.1 Breaking Official Seals
For samples, Form FDA-415a is the Official Seal. A numbered self-locking “US Food
and Drug” metal seal may be used where a paper seal is not possible or practical. This
seal is effective for use on metal drums and baskets where the FDA-415a cannot be used.
Once the sample is packaged for transport to its designated laboratory, it is sealed so that
it cannot be opened at any point without evidence of tampering.
ORA Lab Manual, Volume III, Section 2 – Chain of Custody-Sample Handling
Page 9 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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