Science & Research

Volume III - 6.7 Document/Change History

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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 History Name & Title
Author Approving 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
DFS LMEB
2.5 R 02-06-12 6.1 – 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
DFS LMEB
2.6 R 01-31-13 Header - 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 #######
DFS LMEB
2.7 R 01-09-14 6.4.1. – 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
ORS LMEB

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