Ora Laboratory Manual - Fda Office Of Regulatory Affairs
ADVERTISEMENT
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21Volume III
DOCUMENT NO.: III-2
ORA LABORATORY
Other Laboratory
VERSION NO.: 1.9
Operations
FINAL
MANUAL
EFFECTIVE DATE:
Section 2 – Chain of Custody – Sample
4/17/04
Handling
Revised:
05-02-14
FDA Office of Regulatory Affairs
Office of Regulatory Science
Section 2
Section 2
Chain of Custody – Sample Handling
Contents
2.1
Introduction
2.1.1
Sample Documentation
2.1.2
Definitions
2.2
Protection and Storage of Samples in the Laboratory
2.2.1
Physical Security of FDA/ORA Laboratory Facilities
2.2.2
Security of Samples and Controlled Substances in the Laboratory
2.2.3
Environmental Storage Conditions for Samples
2.3
Custodial Receipt and Storage of Samples
2.4
Receiving Samples from Custodial Storage and Opening the Sample
Package
2.4.1
Receiving Samples from Custodial Storage
2.4.2
Opening the Sample Package
2.5
Intra/Inter Laboratory Splitting and Transferring of Samples
2.5.1
Splitting and Transferring Samples Within the Laboratory
2.5.2
Splitting and Transferring Samples Between FDA/ORA
Laboratories or External (NON-ORA) Entities
2.6
Reserve Samples
2.6.1
Sealing the Reserve Samples
2.6.2
Documenting Reserve Samples
2.7
Returning Samples to Custodial Storage
2.7.1
Returning Samples to the Sample Custodian
2.7.2
Returning Samples to Storage Areas not Controlled by the Sample
Custodian
2.8
Shipping Samples from the Laboratory
2.8.1
Shipping the Entire Sample
2.8.2
Shipping a Portion of the Sample
2.8.3
Documenting Sample Shipment
2.9
Disposition of Samples
2.9.1
Sample Destruction
ORA Lab Manual, Volume III, Section 2 – Chain of Custody-Sample Handling
Page 1 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