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GMP Publications, Inc.

Food & Drug Administration (FDA)
U.S. FDA Code of Federal Regulations & EU ICH Handbooks
Tel: 856-810-7331  Fax: 856-810-7339   
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All U.S. FDA CFR handbooks updated as of April 1st. 2010 - NOW SHIPPING!

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CFR Rule Changes by GXPNews

Just Released July 8, 2010 Federal Register: FDA To Conduct Inspections Focusing on 21 CFR 11 (Part 11) requirements relating to human drugs 

Featured Handbooks - US - EU - Japan GMPs   |   Part 11 Electronic Systems   |  ICH Q7 - Q8 - Q9 & Q10  |   The Auditor's Master Checklist

NEW - US - Canadian and ICH GMP Guidelines!

GXP Electronic Systems Master Handbook - More
Don't forget - You can mix and match parts!  Call for a free quote today! 856-810-7331

Includes all of the Electronic Systems regulations in an easy to carry 3.75" x 6.25" handbook -
Starts at $11.90 each. -
Updated April 1st. 2009

US FDA Title 21 CFR Parts and Guidance References
  -  Part 11 - Electronic Records
  -  Scope and Application 2003
  -  Computerized Systems Used In Clinical Investigations 2007


European Union (EU) Annexes
  -  Annex 11 - Computerized Systems
  -  Annex 15 - Qualification and Validation


Includes:  The Auditing Group Part 11 Check List for Computerized Systems

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