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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    sales@gmppublications.com 

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!

Good Laboratory Practice 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 GLP regulations in an easy to carry 4.5" x 7.5" handbook -
Guidance for all analytical professionals. Starts at $15.95 each. - Updated April 1st. 2009

US FDA Title 21 CFR Parts
  -  11 Electronic Records
  -  58 Good Laboratory Practice
  -  606 GMP for Blood and Blood Components
  -  610 General Biological Products Standards
  -  820 Quality Systems Regulations

US Health and Human Services Public Health
  -  Title 42 CFR Part 493 Laboratory Requirements  

OECD - Organisation for Economic Co-Operation And Development
  -  General Principles of GLP Series 1

 

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GMP Publications, Inc. P.O. Box 335, Medford, NJ 08055   856-810-7331   sales@gmppublications.com