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Volume III - 2.11 Document Change History

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Other Laboratory Operations

Food and Drug Administration

DOCUMENT NO.:

III-2

VERSION NO.:1.9

Section 2 - Chain of Custody – Sample Handling

EFFECTIVE DATE: 04-17-2004REVISED: 05-02-14
Version
No.
Status
(I, R, C)
Date
Approved
Location of Change HistoryName & Title
AuthorApproving Official

1.3

R

02/02/2010

Contents – updated

Footer -  web link updated

Minor revisions made to following sections – 2.1; 2.1.1, 2.1.2, 2.2.3, 2.3, 2.4.2.1, 2.4.2.2, 2.5.2, 2.5.1.1, 2.5.1.2, 2.5.2, 2.6, 2.6.1, 2.6.2, 2.7.2, 2.8, 2.8.1, 2.8.1.1, 2.8.1.2, 2.8.2, 2.8.2.1, 2.8.2.2, 2.9, 2.9.2, 2.10

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 1.4 R 07/20/2010
2.5.1 – changed "interlaboratory" to "intralaboratory"; moved last sentence of paragraph 1 to 2.5.2
2.5.1.2 – changed  "interlaboratory" to "intralaboratory"
2.5.2 – deleted second paragraph; moved last paragraph up
2.5.2.1 and 2.5.2.2 – section titles added
 

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 1.5 R 09/14/20102.5.1.1 – corrected identification on analyst worksheetLMEBLMEB
 1.6R01/11/20112.1.2 – IOM reference changed to Chapter 4
2.2.2.4 – IOM reference changed to Chapter 4
2.4.2.1 – IOM reference changed to Chpater 4
2.10 – updated second reference
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1.7R02/06/2012

2.2 - Title changed

2.2.2.4-updated IOM reference

2.4.2.1-added Subchapter 4.5.4; corrected IOM Exhibit to 4-17

2.5.2-revised "Standard Operation Procedure" in third paragraph; revised last sentence in last paragraph

2.8.2-changed "subdivision" to "portion"

2.8.2.2-revised first sentence in last paragraph

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1.8R01/29/2013

Header-Division of Field Science changed to Office of Regulatory Science

2.10-removed Division of Investigations and Division of Field Science

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1.9R05/02/2014Throughout document – sample custodian changed to Sample Custodian
2.1 – revised section to include reference to LIMS
2.1.1 – added “or LIMS” to section
2.1.2 – added LIMS definition and “orLIMS” to other definitions as applicable
2.2.3 – added “or LIMS’ to second bullet of second paragraph
2.3. added “or LIMS” to section
2.4.1 – added “change of custody” to first paragraph & “or LIMS” to section
2.5.1 – added “or LIMS” to first paragraph & “change of custodianship” to second parag.
2.5.1.2 – added “or LIMS”
2.5.2 - added “or LIMS”
2.5.2.2 - added “or LIMS”
2.6.2 – added “or electronic form” to first & second bullet and “or LIMS” to first bullet
2.7.1 - added “or LIMS”
2.7.2 – added “or electronic form”
2.8 - added “or LIMS”
2.8.2.2 – added “or web application” to 2nd paragraph and “or LIMS record” to 3rd & 4th paragraph
2.8.3 - added “or LIMS”
2.9.1 - added “or LIMS”
2.9.2 – added “or LIMS record” to first paragraph
2.10 – added FACTS Manual and LIMS User’s Manual
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