Ora Laboratory Manual - Fda Office Of Regulatory Affairs Page 4
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21responsible for receiving all samples into the laboratory, both physically and
electronically in FACTS or LIMS, from the collector and assures the samples are stored
under the appropriate environmental conditions until such time as the sample is
transferred to the analyst to whom it is assigned. The Sample Custodian also ensures
proper disposition of all samples in FACTS or LIMS, whether or not the sample is
analyzed.
Samples – Samples are identified as all items, both domestic and import, collected and
identified as Official Samples. Import samples need not be sealed, unless District Policy
dictates, as long as the integrity of the sample is maintained. (See Investigators
Operations Manual, IOM Chapter 4, Official Samples, and Section 2.10 References)
•
702(b) Portion. - In accordance with the provisions of Section 702(b) of the
FD&C Act, a portion of an official domestic sample collected directly from the
manufacturer or if requested under other circumstances, is to be available for
examination or analysis by any person named on the label of the article, or the
owner thereof, or his attorney or agent. The two exceptions to this regulation are
Medical Devices and Import Samples. Medical devices are not specifically
referenced in 21 CFR 2.10(b) and samples being imported or offered for entry
into the United States are exempt under 21 CFR 2.10(b)(4).
The sample, no matter what the content, may be involved in a court proceeding, and
therefore must be preserved by the best means possible. Preservation must be effective
until any legal or regulatory proceedings are terminated.
2.2 Protection and Storage of Samples in the Laboratory
2.2.1 Physical Security of FDA/ORA Laboratory Facilities
The General Services Administration (GSA) has established government-wide minimum
physical security standards for federal facilities. Due to the differences found in federal
facilities, (e.g. size of the facility, number of employees, use and mission of the agencies)
there are five security levels based on minimum standards for each security level. The
categories range from Level I (e.g. a leased space with ten or fewer employees) to level V
(e.g. a large building with many employees and a critical national security mission as
found in the Pentagon).
The FDA Physical Security Staff (HFA-204) maintains a database for all FDA facilities,
their assigned security level, and the physical security standards associated with each
security level.
The FDA Staff Manual Guide f:2280.2, Physical Security in Field Activities,
ORA Lab Manual, Volume III, Section 2 – Chain of Custody-Sample Handling
Page 4 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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