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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!

 

Biologic Handbooks

Biological GMPs - 600, 601 & 610
Biologics/Cell - 600, 601, 610, 1270 & 1271
Bio/Cell/Blood 600, 601, 606, 610, 1270 & 1271
Part 600 - Biological products: general
Part 601 - Licensing - Biologics
Part 610 - General biological products standards
660 - Add. Stds for Diagn. Subst. for Lab. Tests...
680 - Additional Stds for Miscellaneous Products

Blood and Cell Tissue Handbooks

Part 606 - Blood Industry
Parts 606 & 11 Electronic Systems
Part 607 - Est. Reg. for Manuf. of Blood Products...
Parts 600, 601, 606, 610, 1270 & 1271
Biologics - 600, 601, 610, 1270 & 1271
Cell Tissue 1270 Human Tissue for Transplant...
Cell Tissue 1271 Human Cells, Tissues, Cellular...
Cell Tissue Combination - 1270 & 1271
640 - Add. Standards for human blood...


 

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