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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!

NEW!   US and Chinese Part 820 Combination Handbooks -  $5.95 each
 Both US English and Chinese Simplified versions in one easy to carry handbook!

Full US English version 21 CFR Part 820 Quality Systems Regulations coupled with an accurate simplified Chinese translation of Part 820 in one easy to carry handbook.

Section 1 is US version and Section 2 is Chinese.

US and Chinese Part 820 Combination
 

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