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2004D-0443:
GUIDANCE
FOR INDUSTRY ON QUALITY SYSTEMS APPROACH TO PHARMACEUTICAL CURRENT
GOOD MANUFACTURING REGULATIONS
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| Document #
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| Received Date
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| Filed
Date
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| Submitter Code
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| Submitter
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| FR
Date
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| FR
Page
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| Comment Date
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| Files
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| Remarks
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| GDL1
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| 09/29/2004
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| 09/29/2004
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| Federal
Government
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| Guidance
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| pdf,
doc
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| Signature:
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| Guidance
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| NAD1
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| 09/29/2004
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| FDA
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| FDA
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| 10/04/2004
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| 59256-59256
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| 12/03/2004
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| htm
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| Signature:
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| SHUREN, JEFFREY
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| EXT1
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| 10/12/2004
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| 10/08/2004
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| Association
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| American Assn for
Homecare (AAHomecare)
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| pdf
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| Signature:
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| Kay Cox
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| EXT2
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| 10/13/2004
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| 10/12/2004
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| Private Industry
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| Air Products Healthcare
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| pdf
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| Signature:
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| Bob Cucuel
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| EMC1
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| 10/14/2004
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| 10/14/2004
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| Individual Consumer
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| B. Sachau
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| Signature:
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| B. Sachau
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| EXT3
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| 10/25/2004
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| 10/22/2004
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| Private Industry
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| Air Liquide America
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| pdf
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| Signature:
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| Harold Jones
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| C1
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| 11/09/2004
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| 11/08/2004
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| Private Industry
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| Lloyd's Register Serentec,
Inc.
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| pdf
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| Signature:
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| John R. Davis PE
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| EC1
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| 11/03/2004
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| 11/02/2004
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| International Public Citizen
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| Mr. Akio Miura
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| htm
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| Signature:
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| Miura, Akio
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| EC2
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| 11/10/2004
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| 11/09/2004
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| Drug Industry
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| F. Hoffmann-La Roche
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| htm
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| Signature:
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| Roenninger, Stephan
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| EXT4
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| 11/23/2004
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| 11/19/2004
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| Association
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| Compressed Gas Assn
(CGA)
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| pdf
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| Signature:
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| Carl T. Johnson
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| C2
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| 11/26/2004
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| 11/23/2004
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| Drug Industry
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| Pfizer, Inc.
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| pdf
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| Signature:
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| Zena G. Kaufman
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| C3
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| 11/29/2004
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| 11/29/2004
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| Drug Industry
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| Aventis Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| Steve Caffe, MD
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| C4
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| 11/30/2004
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| 11/24/2004
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| Device Industry
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| Computer
Systems Services & Consulting, Inc. (CSSC)
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| pdf
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| Signature:
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| r. Jeff Boatman
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| EMC2
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| 11/24/2004
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| 11/24/2004
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| Device Industry
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| Facility
automation Management engineering (FAME) Systems
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| txt,
Attachment
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| Signature:
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| Dr. King
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| EXT5
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| 12/01/2004
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| 11/19/2004
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| Private Industry
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| Linde Gas, LLC
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| pdf
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| Signature:
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| Michael Skrjanc
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| C5
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| 12/01/2004
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| 12/01/2004
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| Drug Industry
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| Aventis Pasteur, Inc.
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| pdf
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| Signature:
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| Kenneth P. Guito
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| C6
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| 12/01/2004
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| 12/01/2004
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| Association
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| International Assn for Pharmaceutical Science and Technology (PDA)
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| pdf
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| Signature:
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| Victoria Ann Dedrick
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| C7
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| 12/06/2004
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| 12/03/2004
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| Drug Industry
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| Pharmaceutical Research and Manufacturers of America (PhRMA)
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| pdf
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| Signature:
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| Alice E. Till, PhD
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Page last updated
March 2, 2005
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