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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!

 

Clinical Handbooks

The Master GCP Combination Handbooks
GCP - 11, 50, 54, 56, 312, 314 & ICH E2A & E6
GCP - 11,50,54,56,312,314,E2A,E6 & EU Clin. Dir.
 

Individual Booklets - 5 book minimum
Part 50 - Protection of Human Subjects

Part 54 - Financial Disclosure by Investigators

Part 56 - Institutional Review Boards
Part 312 - Investigational New Drug Application
Part 314 - Applications to Market a New Drug
Parts 50, 54 & 56 Handbook
EU Clinical Trials Directives
GCP - Part 11 & 'Computerized Systems Guidance'


 

Laboratory Handbooks

Part 58 - Good Laboratory Practice GLP
Parts 58 GLP & Part 11


 


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