Ora Laboratory Manual - Fda Office Of Regulatory Affairs Page 7
ADVERTISEMENT
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21Controlled substances are secured in a drug storage vault/area where additional security
measures can be effectively implemented in accordance with Section 2.2.1.1 Controlled
Areas. After issuance, additional security controls, (e.g. sample storage, inventory) are
implemented.
2.2.3 Environmental Storage Conditions for Samples
When a Sample Custodian or analyst receives a sample for analysis, he or she assures that
the product is provided proper environmental storage. Samples are stored at frozen,
refrigerated, or ambient temperatures, depending on the type of sample and the analysis
that is being conducted.
Environmental storage conditions are in accordance with those instructions:
•
received with the sample,
•
described in the FACTS or LIMS record for the sample, or
•
instructed by the Laboratory Supervisor or Analyst.
Samples are maintained at the following temperatures:
•
frozen samples are maintained at -28 to -18 °C;
•
refrigerated samples are maintained at 2 to 8 °C; and
•
ambient samples should be protected from heat and moisture.
Refrigerated and frozen sample storage location temperatures are recorded daily. Various
temperature measurement devices (e.g. calibrated thermometers, thermocouples
interfaced with computer systems and temperature recorders) may be used to monitor
temperature control. All sample storage temperature information is recorded daily on
temperature monitoring forms in accordance with the laboratory’s local Standard
Operating Procedures (SOP) or work instructions. See ORA Laboratory Manual,
Volume II, ORA.LAB 5.3 Facilities and Environmental Conditions for general laboratory
requirements.
2.3 Custodial Receipt and Storage of Samples
Samples are delivered to the FDA laboratory receiving area, (e.g. FedEx®, UPS®,
Airborne®, FDA or state personnel, and other private courier).
Any chain of custody form (e.g. from the Office of Criminal Investigations) received
with the sample follows the sample records throughout the laboratory.
ORA Lab Manual, Volume III, Section 2 – Chain of Custody-Sample Handling
Page 7 of 21
This document is uncontrolled when printed: 6/4/2014
For the most current and official copy, check the Internet at
http://
ADVERTISEMENT
0 votes
Related Articles
Related forms
Executive Office Of Elder Affairs Commonwealth Of Massachusetts Elder Abuse Mandated Reporter Form
Business
Form 1b/1c - Petition For Nullity - Payment Agreement - Archdiocese Of Denver - Metropolitan Tribunal & Office Of Canonical Affairs
Legal
Independent Research - Advanced Writing Requirement Course Agreement Form- Office Of Student Affairs
Education
Related Categories
Parent category: Legal