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

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 

Pick up your copy of the Part 11 Electronic Systems Master Handbook! - GXP Academy for On-Site Part 11 Training $6,995 (2 Day all Inclusive!) 866-GXPNews

Standard Drug GMPs Parts 210/211

210/211 Drug Industry GMP Handbook  -  $3.20 ea.

210/211 Drug GMP with Part 11 - $5.95 ea.

210/211 Drug GMP with Keyword Index - $5.95 ea.

210/211 Drug GMP with Part 11 & Keyword Index - $6.90 ea.

210/211 Drug GMP with Part 11 & 820 QSR - $6.90 ea.

210/211 Drug GMP with Part 58 GLP - $5.95 ea.

210/211 Drug GMP with Part 820 QSR  - $5.95 ea.

210/211 Drug GMP with Preambles  - $5.95 ea.

Combination 210/211 Drug GMPs

GMP Std. Combo Parts 11, 210/211, 820 & Q7 - $9.90

US GMPs, Parts 11, 58, 210/211, 600, 610, 610, & 820 - $9.90

210/211 Drug GMP with Guidance GMPs for 21 Century - $9.90

Basic EU GMPs with US Standard GMPs - $12.90

Med Dev Quality Sys. Manual w/11, 210/211 & 820 - $15.90

 

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