Ora Laboratory Manual - Fda Office Of Regulatory Affairs Page 6
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212.2.2 Security of Samples and Controlled Substances in the
Laboratory
2.2.2.1 Custodial Storage of Samples
The Sample Custodian is responsible for the initial and final stages of sample storage.
Samples are secured in a storage area where additional security measures can be
effectively implemented in accordance with Section 2.2.1.1 Controlled Areas.
2.2.2.2 Analyst Storage of Samples
The analyst is responsible for the integrity, security, and proper handling of the sample
while it is in his or her possession. All portions of the sample in the analyst’s possession
are kept in locked storage (e.g., analyst’s lockable cabinet) when not under the analyst’s
control. The analyst can use temporary seals when appropriate.
2.2.2.3 Temporary Sealing of Samples
When locked storage is not possible (e.g. sample needs refrigeration and is stored in an
unlocked, “common” laboratory refrigerator overnight), a temporary seal is used to
demonstrate that sample integrity was maintained. The temporary seal is an Official Seal
(FDA-415a) used for securing a sample for a short period. When the temporary seal is
broken, the seal is initialed and dated.
The temporary seal and the following information are submitted with the worksheet:
• the fact a temporary seal was used,
• how the temporary seal was used, and
• the quoted temporary seal.
2.2.2.4 Import Samples
Import Samples are Official Samples and require the same integrity as domestic Official
Samples. Import Samples need not be sealed, unless District Policy dictates, as long as
the integrity of the sample is maintained. (See Investigations Operations Manual, IOM
Chapter 4,Subchapter 4.1.4 - Official Samples)
2.2.2.5 Controlled Substances (Schedule I and II drugs)
ORA Lab Manual, Volume III, Section 2 – Chain of Custody-Sample Handling
Page 6 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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