Ora Laboratory Manual - Fda Office Of Regulatory Affairs Page 5
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provides additional instructions for physical security in FDA
field offices. This includes building security, protection of official samples, visitor
control, document security, controlled substances (Schedule I and II), alcohol (95% and
absolute) and other laboratory items such as platinum dishes, United States
Pharmacopoeia (USP) reference standards, National Institutes of Standards Technology
(NIST) test weights, and syringes (1 mL to 20 mL).
2.2.1.1 Controlled Areas
The following areas are designated as controlled areas within the laboratory and need
additional protective measures to ensure the integrity of the security interest involved:
• Drug vault/storage area;
• Solvent storage area;
• Alcohol storage area;
• Sample storage area;
• Radioactive Material Area;
• Infectious Materials Room;
• Sterility Testing Room;
• PCR Room;
• Document room;
• Computer room; and
• Mail room
For these controlled areas, the following additional protective measures are provided:
• Access is limited to only those employees who need access in the performance of
their official duties.
• Entrances are secured at all times or monitored by an authorized employee or
security guard.
• Doors are equipped with high security locks or card readers with alarm contacts.
High security locks are keyed “separately” from the building master key system.
Card readers are keyed “alike.”
• Controlled areas are cleaned only during normal working hours and under the
supervision of an authorized employee or security guard.
• Locks or their combinations are changed if the key or combination has been
compromised, if the area has been discovered unsecured or unattended, or when
an employee no longer needs access due to transfer, termination, retirement.
ORA Lab Manual, Volume III, Section 2 – Chain of Custody-Sample Handling
Page 5 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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