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Volume III - 6.7 Document/Change History

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Other Laboratory Operations

Food and Drug Administration

DOCUMENT NO.:

III-06

VERSION NO.:2.7

Section 6 ORA Method Development and Validation Program

EFFECTIVE DATE:
04-02-04
REVISED: 01-09-14
Version
No.
Status
(I, R, C)
Date
Approved
Location of Change HistoryName & Title
AuthorApproving Official
1.2
R
06-23-05
 

LMEB

LMEB

2.0
R
12-06-06
Chapter underwent major revision to reflect the current Method Development and Validation Program.

LMEB

LMEB

2.1
R
06-06-08
6.5.2.2 and 6.5.2.3 - Calls for Proposals changed from quarterly to semiannually.Reference 2. changed to the accessible policy on publication.

LMEB

LMEB

2.2
R
08-15-08
Table of Contents - 6.5.2.1-6.5.2.7 revised
Appendix III - added
6.4.3 - added “the Centers” to second paragraph
6.5.2.1- 6.5.2.7 - revised
6.5.2.6 - revised sixth paragraph

DFS

LMEB

2.3
R
12-03-08
6.3.2 - inserted “in” after described
6.5.1. Technology Exploration - changed implemented to accepted
6.5.2.3 - added (Appendix III) at end of first paragraph
6.5.2.4 - updated SOP information in fourth paragraph
6.5.2.5 Scientific Articles - added last paragraph

DFS

LMEB

 2.4 R 07-13-11

6.5.2.2 1. a., third bullet - change "or" to "and"
Appendix I - replaced
Appendix III replaced

DFSLMEB
2.5R02-06-126.1 – added FDA Office of Foods Guidelines for Validation in Food to fourth sentence
6.2 – deleted “of this program”; added and/or in conjunction with the Office of Foods to third sentence
6.3 – deleted first sentence
6.3.2 – deleted “Sources” from the title and deleted sentence
6.4 – changed Associate Commissioner for Regulatory Affairs to  Office of Regulatory Affairs Associate Commissioner
6.5.2 – added NOTE: and revised section for CARTS implementation
6.5.2.1 – changed “semiannually” to “at least annually” in second paragraphy
6.5.2.4 – added last two sentence to first paragraph
DFSLMEB
2.6R01-31-13Header - Division of Field Science and DFS changed to Office of Regulatory Science and ORS throughout the document
6.5.2.6 – RPN Project ####### changed to CARTS Project #######
DFSLMEB
2.7R01-09-146.4.1. – ORO changed to OO
6.4.3 – added last sentence to 1st paragraph
6.4.4 – added 3rd paragraph
6.4.5 – revised 1st & 2nd bullets
6.5.2.1 – revised 1st paragraph
6.5.2.2 – revised section with CARTS information
6.5.2.3 – revised section with CARTS information
6.5.2.4 – revised section with CARTS information
6.5.2.6 – revised section with CARTS information
6.5.2.7 – revised 2nd paragraph
6.6.2 – revised section with CARTS information
Appendix I – changed to Additional Project Proposal Information
Appendix II - revised
ORSLMEB